Create a Report
Please provide report title
Please provide location
Please provide details
Get alerts and updates for your case!
This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.
Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Please accept our Terms & Conditions
Add photos or video
We recommend photos and videos to help explain your report
Add Photo/Video
Email or SMS copy of report
Enter below to get emailed a copy of your report, or sms a link to your report
Please provide email or phone
Please provide email or phone
Please accept our Terms & Conditions
Thank you for your report!


IMPORTANT - Your report is queued
It may take up to 12 hours to process your report.


Email us at support@safelyhq.com if you have questions.

Report by
Loading...
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

Medical Devices

Updated: February 5, 2024 2:03 PM
Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology and operating room-specific kits and... See More trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist. Under the Nurse Assist voluntary recall, this product is being recalled due to the potential for a lack of sterility assurance which could result in non-sterile product. There have been no reports of patient harm.

In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.

After reviewing the impact of the Nurse Assist recall, Cardinal Health has identified the affected Covidien and Cardinal Health™ brand codes and lot numbers, which you can see in the link below. Customers who received the listed lots were given instructions to:
1. QUARANTINE affected kits/trays.
2. ALERT clinicians of the recalled component(s).
3. AFFIX a WARNING LABEL to the front of each kit/tray so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s).
4. NOTIFY other departments, facilities or customers within the customer’s hospital system, if they have transferred the affected kits/trays, and provide a copy of the notice and recall acknowledgement form to them.
5. RETURN their enclosed Acknowledgment Form confirming receipt of this action and the completion of over labeled product.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Cardinal Health
Brand name: Covidien and Cardinal Health
Product recalled: Expanded list of Urology and OR room specific kits and trays
Reason of the recall: Potential lack of sterility assurance which could result in non-sterile product
FDA Recall date: February 05, 2024

Source: fda.gov
See Less
303


Aligned Medical Solutions, initiated a nationwide recall of Convenience kits containing saline because the Product cannot be verified as having the required sterility assurance level. Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Aligned Medical Solutions distributed these kits... See More nationwide in the USA. Recalled Product(s) were manufactured from 06/028/2022 to 11/20/23 and distributed from 06/08/2022 to 11/27/2023. No injuries have been reported to date.

Water-based medical products that are nonsterile and potentially contaminated with bacteria could cause serious or life-threatening infections. Patients who are elderly, critically ill, have weak immune systems (including newborn infants, pregnant women, and cancer patients), or have chronic diseases are particularly at risk of infection. However, other patients could also develop infections after they are exposed to contaminated water-based medical products.

Recalled products apply to the following kits: AMS10833 Local Lower Extremity Pack I, AMS12947 In-House Ocular Pack, AMS12947A In-House Ocular Pack, and AMS13043 Closure Kit. Product(s) can be identified by the pack label inside the sterile barrier of the convenience kit. Details are attached.

These convenience kits contain the recalled Nurse Assist Sterile Saline, Brand Name - Medline Medical part # DYND40540 110ML Sterile Saline Cup or Nurse Assist Sterile Saline Brand Name - McKesson Medical part # 560284 100ML Sterile Saline Bottle, which has been recalled because the Nurse Assist product cannot be verified as having the required sterility assurance level (SAL) of 10-6. See Nurse Assist Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation

Customers who have affected products should immediately review their inventory and quarantine all affected kits. Contact the Quality Department for further instructions on labeling and replacement products if needed. Customers will be provided with a label that is to be placed on the packs containing the recalled Nurse Assist Sterile Saline. Aligned Medical Solutions is notifying its distributors by email and will arrange for labels to identify the packs with the recalled sterile saline. At the time the kit is opened for use, Nurse Assist sterile saline should be identified, and quarantined according to the medical waste policies in effect in your institution. All other components in the kit are not affected by this recall. Aligned Medical Solutions will also arrange for replacement sterile saline to be sent for all recalled product[s].

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Aligned Medical Solutions
Brand name: Aligned Medical Solutions
Product recalled: Convenience kits containing saline
Reason for the recall: The product cannot be verified as having the required sterility assurance level
FDA Recall date: January 23, 2024

Source: fda.gov
See Less
303


Getinge / Atrium Medical Corporation notified affected customers of a nationwide recall (medical device correction) for certain Atrium Express Dry Suction Dry Seal Chest Drains in response to a voluntary medical device recall initiated by a supplier, Nurse Assist. On November 8, 2023, Getinge received notice from... See More Nurse Assist, LLC that its Sterile Water, USP, 30mL syringes were being recalled because they could not be verified to be sterile. The affected products were manufactured from November 20, 2020, to September 5, 2023, and distributed from December 18, 2020, through November 8, 2023.

Pre-packaged with every Express chest drain, the 30mL sterile water syringe is intended to fill the air leak monitor chamber for air leak detection during or after initial device set-up, if desired. During a chest drain knock-over event (device not kept in upright position), the water in the air leak monitor chamber could migrate from the air leak monitor chamber to the drainage fluid collection chamber and the patient could potentially be exposed to an infectious pathogen from the water supplied by Nurse Assist. If a patient was already successfully treated with one of the affected Express chest drains, there is no expected negative impact.

The affected Atrium Express Drains are as follows:
Product part number, product name, and UDI Device Identifier:
- 4000-100N, DRAIN, EXPRESS SINGLE W/AC, 00650862115130
- 4050-100N, DRAIN, EXPRESS BRU W/AC, 00650862115147
The affected lot numbers list is attached.

Please examine your inventory immediately to determine if you have any of the Atrium Express Dry Suction Dry Seal Chest Drains with the REF and LOT numbers listed in this notice. Should you have any affected product, please forward this notification to the clinical area(s) of your facility where this product may be used/stored. The LOT Number (6 digit code) can be found on the product label (illustrated in Figures 1 and 2 attached.)

If visualization of active pneumothorax is not needed, keep the affected Express chest drains and set up without water. Use the Express chest drain as intended by replacing the sterile water syringe provided with the drain with a new syringe filled with sterile water using aseptic technique.

Return the affected Express chest drains to Getinge/Atrium Medical Corporation via Return Good Authorization (RGA). If you have any affected Express 4000-100N and/or 4050-100N from the above-listed lots, this product can be returned. If you are a distributor who has shipped any affected products to customers, please forward this information to their attention for appropriate action.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Getinge/Atrium Medical Corporation
Brand name: Atrium
Product recalled: Express Drains
Reason of the recall: Syringes provided with Express Drains could not be verified to be sterile.
FDA Recall date: January 04, 2024

Source: fda.gov
See Less
303


ResMed (NYSE: RMD, ASX: RMD) is conducting a voluntary global field action to update its guides for all masks with magnets to inform users about potential magnetic interference when magnets are near certain implants and medical devices in the body. This voluntary field correction does not require... See More a return of a mask with magnets unless the patient is contraindicated. All ResMed masks containing magnets are safe when used in accordance with the Field Safety Notice and updated Instructions for Use in the guides of affected masks. ResMed masks with magnets were distributed nationwide and globally from 2014 to November 2023. ResMed has submitted five reports of serious harm (medical intervention/hospitalization) that were potentially related to magnetic interference of a mask with a magnet with an implanted device to relevant regulatory authorities. To date, no permanent injuries or deaths have been reported.

A patient is contraindicated where they, or anyone in close physical contact while using the mask, have the following:
- Active medical implants that interact with magnets (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps).
- Metallic implants/objects containing ferromagnetic material (i.e., aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye).

Patients using the masks with magnets or anyone in close physical contact with mask magnets should keep the magnets at a safe distance of 6 inches (150 mm) away from implants or medical devices that may be adversely impacted by magnetic interference. Refer to the ResMed Magnet Update website for more information about the updates issued to contraindications and warning labels.

ResMed is notifying affected customers and guiding specific actions. ResMed has provided a patient letter to healthcare providers that includes additional information regarding the contraindications and warnings for patients with the affected medical implants or devices. Patients should consult their physician and/or manufacturer of their implant or other medical device if they require additional information on the potential adverse effects of magnetic fields for their device.

For patients who, or anyone in close physical contact, do not have a contraindicated device, no action is needed.

The impacted Mask with Magnet product(s) can be identified by the model number: AirFit N10, AirFit F20, AirTouch F20, AirFit N20, AirTouch N20, AirFit F30, AirFit F30i on the cushion or frame of the masks. ResMed voluntarily updated its contraindications and warning labels in response to new information obtained through post-market surveillance and industry practices.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: ResMed
Brand name: ResMed
Product recalled: Masks with magnets
Reason of the recall: Potential for magnetic interference near certain implants and medical devices
FDA Recall date: December 21, 2023

Source: fda.gov
See Less
303


Medline Industries, LP. announced a voluntary nationwide recall on October 10th, 2023, of several lots and SKUs of Tracheostomy Care and Cleaning Trays. The Tracheostomy Care and Cleaning Trays include a tracheostomy brush as a component that may have sharp edges at the tip that can puncture... See More tubing during use and/or cause user injury during handling. The voluntary recall includes the following item numbers and lot numbers, distributed nationwide from March 21, 2022, through October 10, 2023. To date, Medline Industries, LP. has received one adverse event associated with this product.

In addition, complaints describe bristles of the tracheostomy brush detaching before and potentially during use. If bristles reach a patient’s airway, they may cause unexplained increases in sputum or pulmonary secretions, signs of infection, or difficulty breathing. If a patient exposed to the brush experiences any of these signs or symptoms, they should seek medical attention promptly.

Tracheostomy Care Trays are medical devices intended to be used for the care and maintenance of a stoma site. These trays may be used in various healthcare environments including acute care settings, such as hospitals, and long-term care settings such as skilled nursing facilities. The tracheostomy brush component is used to clean tracheostomy tubing and cannulas. Tracheostomy cannulas should always be rinsed following brush cleaning. This component is packaged within Tracheostomy Care and Cleaning Trays, which contain multiple components packaged together.

Affected product(s) can be identified by the lot number indicated on the medical device packaging. A list of the affected products is attached.

Medline Industries, LP. is implementing corrective and preventative actions. Medline Industries, LP. notified its distributors and consumers by First Class Mail and email on October 16, 2023, and instructed consumers to destroy and dispose of any affected product per local and state regulations. No product is to be returned to Medline Industries, LP. Any consumers or distributors that have a product that is being recalled should stop using the product and contact Medline Industries, LP.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Medline Industries, LP
Brand name: Medline
Product recalled: Tracheostomy Care and Cleaning Trays
Reason for the recall: Device & Drug Safety - Potential Component Defect
FDA Recall date: December 20, 2023

Source: fda.gov
See Less
303


On November 21, 2023, Busse Hospital Disposals initiated a nationwide recall of medical device kits and trays containing (1) Nurse Assist part 6240, Stericare 100ML Sterile Saline Botle. This is the only saline contained in the trays/kits. Busse initiated this recall in direct response to Nurse Assist... See More LLC’s, November 6, 2023, recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to potential lack of sterility assurance, which could result in a nonsterile product. To date, Busse has not received any reports of serious injuries or deaths associated with this recall.

In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.

All distributors who are affected have been identified and notified through recall letters. The devices that have been shipped to your facility and identified as affected may be destroyed following instructions on the recall. The recalled Busse kits/trays were manufactured and distributed to medical device distributors from July 2022 to November 2023.

The following products, which contain Nurse Assist Part#6240, Stericare 100ML Sterile Saline Botle have been recalled:
- Catalog Number: 800, Product Description: Tracheostomy Care Tray – Sterile – Latex Free UDI: (01)00849233010000, Lot Numbers: (2210099, 2210135, 2210337, 2210377, 2310181, 2310233, 2310291)
- Catalog Number: 1443, Product Description: Dressing Change Tray – Sterile – Latex Free UDI: (01)00849233010727, Lot Numbers: (2210077, 2210112, 2310275, 2310331)
- Catalog Number: 9251R1, Product Description: Tracheostomy Care Set – Sterile – Latex Free UDI: (01)00849233011069, Lot Numbers: (2210087, 2210165, 2310361)
Products can be identified by locating the information above on their respective labeling.

Busse has notified both the FDA and affected distributors of the recall through direct communications. We remain commited to ensuring the safety and well-being of our customers.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Busse Hospital Disposals
Brand name: Busse Hospital Disposals
Product recalled: Medical Device Kits and Trays
Reason of the recall: Device & Drug Safety - Potential Lack of Sterility
FDA Recall date: December 20, 2023

Source: fda.gov
See Less
303


In direct response to the Nurse Assist, LLC voluntary product recall (which included products supplied to Cardinal Health used in Covidien and Cardinal Health™ brand kits and trays), Cardinal Health issued a medical device recall on December 5, 2023, for its Covidien and Cardinal Health™ brand urology... See More and operating room-specific kits and trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist. Under the Nurse Assist voluntary recall, this product is being recalled due to the potential for a lack of sterility assurance which could result in a non-sterile product. There have been no reports of patient harm.

In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events. Our top priority is the safety of patients.

After reviewing the impact of the Nurse Assist recall, Cardinal Health has identified the affected Covidien and Cardinal Health™ brand codes and lot numbers, you can see them in the link below.

Customers who received the listed lots were given instructions to:
- QUARANTINE affected kits/trays.
- ALERT clinicians of the recalled component(s).
- AFFIX a WARNING LABEL to the front of each kit/tray so that it is visible to clinicians, instructing them to remove and discard the recalled component(s).
- NOTIFY other departments, facilities, or customers within the customer’s hospital system, if they have transferred the affected kits/trays, and provide a copy of the notice and recall acknowledgment form to them.
- RETURN their enclosed Acknowledgment Form confirming receipt of this action and the completion of over labeled product

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Cardinal Health
Brand name: Covidien and Cardinal Health
Product recalled: Urology and OR room-specific kits and trays
Reason for the recall: Potential lack of sterility assurance which could result in non-sterile product
FDA Recall date: December 07, 2023

Source: fda.gov
See Less
303


Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Novum IQ syringe infusion pump. The Correction is due to the potential for an incomplete infusion following one or more downstream occlusion alarms. Baxter notified impacted customers in October and is developing... See More a software upgrade to resolve the issue. There have been no reports of serious injury associated with this issue to date. This infusion pump was distributed in the United States.

Baxter has identified that after one or more downstream occlusion alarms occur on the Novum IQ syringe pump, the pump may display an “Infusion Complete” alarm despite fluid remaining in the syringe. This could lead to an underdose and/or interruption of therapy. The difference between the remaining volume to be infused displayed on the pump and the volume left in the syringe is dependent on the number of occlusion alarms encountered during an infusion and the size of the syringe being used.

If a patient does not receive the intended dose of a prescribed medication, serious or critical adverse health consequences may occur. Potential health consequences are dependent on multiple patient-specific factors (such as disease state as well as age and weight of the patient involved, and the care area where they are treated), occlusion pressure settings, the number of occlusions that occurred, the size of the syringe used, and the therapy being delivered.

This Urgent Medical Device Correction applies to Novum IQ syringe infusion pump with product code 40800BAXUS. Baxter has contacted affected customers and is developing a software update to resolve the issue. Until the software update is available, customers can continue to use Novum IQ syringe infusion pumps with the following reinforced guidance provided by Baxter:

- As stated in the pump’s Operator’s Manual, users should choose the smallest compatible syringe size necessary to deliver the fluid or medication.
- Prior to beginning an infusion, users should ensure the downstream occlusion pressure setting is appropriate for the clinical scenario. Consistent with standard clinical practice, users should always check for clamped lines and other sources of downstream occlusion prior to and during therapy. Pressure setting selection guidelines and instructions for downstream occlusion resolution can be found in section 8.8 of the Operator’s Manual.
- Per standard clinical practice, users should continue to monitor the “Volume to be Infused” and the volume delivered while therapy is in progress. This is especially true after a downstream occlusion alarm has occurred. Users should also take note of the initial volume and compare it to the final volume in the syringe. If the total dose is not delivered upon the “Infusion Complete” alarm, users should reprogram the pump and deliver the remaining volume as necessary.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Baxter International, Inc.
Brand name: Baxter
Product recalled: Novum IQ syringe infusion pump.
Reason of the recall: Potential for an incomplete infusion following one or more downstream occlusion alarms.
FDA Recall date: November 30, 2023

Source: fda.gov
See Less
303


Nurse Assist, LLC initiated a voluntary recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, due to the potential for a lack of sterility assurance, which could result in a nonsterile product. The product was distributed in the United States and Canada. To... See More date, Nurse Assist, LLC has not received any reports of adverse events for these products.

In populations most at risk, such as patients who are immunocompromised, there is a possibility that the use of the affected product could potentially result in severe or life-threatening adverse events.

Recalled Product was distributed from November 1, 2021 to September 18, 2023. Recalled products include the following products, these products may be packaged inside kits:

Product: 0.9% Sodium Chloride Irrigation USP, Size: 100 mL bottles, 250 mL bottles, 500 mL bottles, 1000mL bottles, 3.1oz spray can, 7.1oz spray can, 3mL syringes, 5mL syringes, and 10mL syringes.

Product: Sterile Water for Irrigation USP, Size: 100 mL bottles, 250 mL bottles, 500 mL bottles, 1000mL bottles, 120 mL cups, 10mL syringes, and 30mL syringes

Expiration dates range from November 1, 2023 to September 18, 2025 for all part numbers, with the exception of part number 1030A (USP STERILE WATER SYRINGE, UDI+B15010304N), which has an expiration date range from November 1, 2023 to September 18, 2028.

You can find detailed product information on the link below.

Recalled products may be repackaged into medical device convenience kits.

The potential for a compromised sterile barrier was identified during routine product testing. Further investigations prompted a widening of product scope out of an abundance of caution.

Consumers who have these products should stop using them and contact their distributor or Nurse Assist, LLC for return authorization.

Nurse Assist, LLC is notifying its distributors and customers by electronic communication and letter and is arranging for replacement of all recalled products. Users are being requested to coordinate the return of product with Nurse Assist, LLC.

Company name: Nurse Assist, LLC
Brand name: Multiple brand names
Product recalled: 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP
Reason of the recall: Lack of sterility assurance
FDA Recall date: November 06, 2023

Source: fda.gov
See Less
303


On September 28, 2023, Medtronic issued this notification to inform the public of stolen defective McGRATH™ MAC video laryngoscopes that have been offered for sale illegally by unauthorized third parties through various social media platforms. These affected products did not pass Medtronic’s rigorous quality tests established for... See More the product, were not released for sale, distribution, or importation and were designated for destruction. These affected products are defective and should not be used. Medtronic is working closely with regulatory authorities and law enforcement organizations to help ensure that unauthorized advertisements are being removed as identified, and actions to recover the stolen defective products are underway. McGRATH™ MAC video laryngoscopes purchased directly from Medtronic or via its authorized distributors are not affected by this safety notice.

The McGRATH™ MAC video laryngoscope is a device used to facilitate intubation of the trachea. The use of a defective McGRATH™ MAC video laryngoscope may result in patient harm, including failed laryngoscopy and/or intubation, potentially resulting in respiratory failure (including hypercarbia), hypoxia (leading to bradycardia, dysrhythmias), hypercapnia, tissue damage/tissue trauma and/or a delay to treatment (prolonged procedure/extended hospitalization).

A population of products affected by this notice (Item Code 301-000-000) are marked with the serial numbers listed below. Additionally, any McGRATH™ MAC video laryngoscopes without a serial number marked on the device are affected by this notice. The stolen defective products are not packaged in the labeled packaging containers shown below:

CONFORMING devices can be identified by the presence of serial number and packaged in either version of container shown.

Patient safety remains at the core of the Medtronic Mission to alleviate pain, restore health, and extend life. Medtronic urges healthcare professionals to purchase products only from trusted and reliable sources, such as directly from Medtronic or its authorized distributors.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Medtronic
Brand name: Medtronic
Product recalled: McGRATH MAC video laryngoscopes
Reason of the notification: Stolen Potentially Defective
FDA Recall date: October 19, 2023

Source: fda.gov
See Less
303


Last 30 days