Medical Devices

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: www.fda.gov

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: www.fda.gov

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: www.fda.gov

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: www.fda.gov

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: www.fda.gov

1, 2023, through September 21, 2023. These items were sold at those stores between June 1, 2023, and October 4, 2023. To date, Family Dollar has not received any consumer complaints or reports of illness related to this voluntary recall. This recall only applies to the following 23 states as no Family Dollar stores in any of the other states received any products subject to this recall: AL, AR, AZ, CA, CO, FL, GA, ID, KS, LA, MS, MT, ND, NE, NM, NV, OK, OR, SD, TX, UT, WA, and WY.

You can see the list of the recalled products in the link below.

This recall goes to the retail store level. Not all of the products listed were sent to all stores. Family Dollar has notified its affected stores asking them to check their stock immediately and to quarantine and discontinue the sale of any affected product.

Customers who purchased affected products may return them to the Family Dollar store where they were purchased without a receipt.

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: Family Dollar
Brand name: Multiple brands
Product recalled: Over-the-Counter Drug and Medical Device products
Reason of the recall: Products were stored outside of labeled temperature requirements
FDA Recall date: October 10, 2023

Source: www.fda.gov

of these distributed products. 4 of the products (PrestiBio Breastmilk Alcohol Test Strip, PrestiBio™ Ketone Test Strips, HealthyWiser KetoFast™ Ketone Test Strips and DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test) have been violatively distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA. These products have been distributed to distributors in California, New York, New Jersey, and Florida, and they may have been further sold to end consumers national-wide across the United States. To date, there has not been any reported injury due to the use of any of the products.

Recalled products were manufactured and distributed from March 2021 to November 2022. The following styles/models/UDI have been recalled:

No. Product Name UDI Number Lot Number to be Recalled
1 One Step® Pregnancy Test B512100011 3-H25052-20UMI 3-H07102-20UMI
2 One Step® Ovulation Test* B512200011 3-L12121-20UMI 3-L07102-20UMI
3 HealthyWiser UriTest™ 10 Parameter Reagent Test Strips for Urinalysis None** URS-1-2104-01 URS-1-2102-02 URS-1-2105-01 URS-1-2106-02 URS-1-2110-02
4 HealthyWiser UriTest™ UTI Test Strips None** URS-1-2102-03 URS-1-2106-01 URS-1-2202-01-Q URS-1-2204-01 URS-1-2207-01 URS-1-2209-01
5 HealthyWiser KetoFast™ Ketone Test Strips None** URS-1-2104-02
6 HealthyWiser pH-Aware™ pH Test Strips None** URS-1-2105-01-Q URS-1-2105-02-Q URS-1-2108-01-Q URS-1-2109-01-Q URS-1-2111-01-Q
7 hCG Pregnancy Cassette None** hCG-M5-2101-01 hCG-M5-2104-01 hCG-M5-2106-01 hCG-M5-2107-01 hCG-M5-2108-01 hCG-M5-2110-01 hCG-M5-2202-01 hCG-M5-2202-02hCG-M5- 2202-03 hCG-M5-2203-01 hCG-M5-2204-01 hCG-M5-2204-02 hCG-M5-2204-03 hCG-M5-2206-01 hCG-M5-2206-02 hCG-M5-2207-01 hCG-M5-2210-02
8 Am I Pregnant Pregnancy Midstream Test None** hCG-MHM-2205-01 hCG-MHM-2207-01 hCG-MHM-2207-02 hCG-MHM-2207-03 hCG-MHM-2207-04 hCG-MHM-2208-01 hCG-MHM- 209-01 hCG-MHM-2209-02 hCG-MHM-2209-03 HCG-MHM-2210-01 HCG-MHM-2210-02
9 hCG Pregnancy Strips None** hCG-S-2210-03
10 PrestiBio™ Breastmilk Alcohol Test Strip None**
11 PrestiBio™ Ovulation Strips*** None** Any Lot Number
12 PrestiBio™ Ovulation and Pregnancy Strips None** Any Lot Number
13 PrestiBio™ Pregnancy Strips**** None** Any Lot Number
14 PrestiBio™ Rapid Detection Pregnancy Test Midstream None** Any Lot Number
15 PrestiBio™ Ketone Test Strips None** Any Lot Number
16 PrestiBio™ Urinalysis Test Strip None** Any Lot Number
17 DiagnosUS® One Step LH Ovulation Test (Strip) None** LH-S-2204-01-S LH-S-2111-01-S
18 DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test None** COV-UL-2208-01
19 DiagnosUS® One Step FSH Menopausal Test (Strip None** FSH-S-2106-01 FSH-S-2108-01 FSH -S-2111-01-S
20 Lem Fertility hCG Pregnancy Urine Test None** hCG -S-2112-02
21 Lem Fertility LH Ovulation Test (Strip) None** LH-S-2112-01
22 DiagnosUS® hCG Pregnancy Urine Test Strip Format None** hCG-S-2101-01 hCG-S-2111-01-S hCG-S-2112-01
23 DiagnosUS® hCG Pregnancy Urine Test Cassette Format None** hCG-M5-2103-01 hCG-M5-2106-02 hCG- M5-2109-01 hCG- M5-2203-01
24 DiagnosUS® hCG Pregnancy Serum/Urine Test Cassette Format None** hCG-M5-2106-03
25 DiagnosUS® Pregnancy Test Midstream 710928980000 hCG-M11-2103-01 hCG-M11-2105-01
26 DiagnosUS® Ovulation Predictor Midstream 697691538914 LH-M11-2101-01 LH-M11-2105-01 LH-M11-2106-01 LH-M11-2107-01

Consumers who still have unused tests manufactured by Universal Meditech Inc. should stop using the device immediately and discard any remaining stock in the trash, or ship back to Universal Meditech at our expense.

In case you experience harm from these products, 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: Universal Meditech Inc.
Brand name: Healthy Wiser and more
Product recalled: Test kits
Reason of the recall: Product Safety/Defect
FDA Recall date: September 22, 2023

Source: www.fda.gov

products (PrestiBio Breastmilk Alcohol Test Strip, PrestiBio™ Ketone Test Strips and HealthyWiser KetoFast™ Ketone Test Strips) has been violatively distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA. These products have been distributed to distributors in California, New York, New Jersey, and Florida, and they may have been further sold to end consumers national-wide across the United States. To date, there has not been any reported injury due to the use of any of the products.

Recalled products were manufactured and distributed from March 2021 to November 2022. The following styles/models/UDI have been recalled:

No. Product Name UDI Number Lot Number to be Recalled
1 One Step® Pregnancy Test B512100011 3-H25052-20UMI 3-H07102-20UMI
2 One Step® Ovulation Test* B512200011 3-L12121-20UMI 3-L07102-20UMI
3 HealthyWiser UriTest™ 10 Parameter Reagent Test Strips for Urinalysis None** URS-1-2104-01 URS-1-2102-02 URS-1-2105-01 URS-1-2106-02 URS-1-2110-02
4 HealthyWiser UriTest™ UTI Test Strips None** URS-1-2102-03 URS-1-2106-01 URS-1-2202-01-Q URS-1-2204-01 URS-1-2207-01 URS-1-2209-01
5 HealthyWiser KetoFast™ Ketone Test Strips None** URS-1-2104-02
6 HealthyWiser pH-Aware™ pH Test Strips None** URS-1-2105-01-Q URS-1-2105-02-Q URS-1-2108-01-Q URS-1-2109-01-Q URS-1-2111-01-Q
7 hCG Pregnancy Cassette None** hCG-M5-2101-01 hCG-M5-2104-01 hCG-M5-2106-01 hCG-M5-2107-01 hCG-M5-2108-01 hCG-M5-2110-01 hCG-M5-2202-01 hCG-M5-2202-02hCG-M5- 2202-03 hCG-M5-2203-01 hCG-M5-2204-01 hCG-M5-2204-02 hCG-M5-2204-03 hCG-M5-2206-01 hCG-M5-2206-02 hCG-M5-2207-01 hCG-M5-2210-02
8 Am I Pregnant Pregnancy Midstream Test None** hCG-MHM-2205-01 hCG-MHM-2207-01 hCG-MHM-2207-02 hCG-MHM-2207-03 hCG-MHM-2207-04 hCG-MHM-2208-01 hCG-MHM- 209-01 hCG-MHM-2209-02 hCG-MHM-2209-03 HCG-MHM-2210-01 HCG-MHM-2210-02
9 hCG Pregnancy Strips None** hCG-S-2210-03
10 PrestiBio™ Breastmilk Alcohol Test Strip None** Any Lot Number
11 PrestiBio™ Ovulation Strips*** None** Any Lot Number
12 PrestiBio™ Ovulation and Pregnancy Strips None** Any Lot Number
13 PrestiBio™ Pregnancy Strips**** None** Any Lot Number
14 PrestiBio™ Rapid Detection Pregnancy Test Midstream None** Any Lot Number
15 PrestiBio™ Ketone Test Strips None** Any Lot Number
16 PrestiBio™ Urinalysis Test Strip None** Any Lot Number

Consumers who still have these unused tests manufactured by Universal Meditech Inc. should stop using the device immediately and discard any remaining stock in the trash or ship back to Universal Meditech.

In case you experience harm from these products, 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: Universal Meditech Inc.
Brand name: Healthy Wiser and more
Product recalled: Test kits
Reason of the recall: Due to lack of appropriate premarket clearance or approval which potentially could result in inaccurate test results
FDA Recall date: August 31, 2023

Source: www.fda.gov

complaints relating to this problem have been reported. In the U.S., the Carina ventilator was distributed from March 16, 2009, through October 20, 2012. Outside the U.S., the Carina ventilator was distributed from May 23, 2007, through February 3, 2022.

The recalled product is:
- Dräger Carina Sub-Acute Care Ventilator, Part Number: 5704110, UDI Number: 04048675398516.

Although Dräger discontinued production of the Carina ventilator in 2019, the company is planning to remove the foam from Carina ventilators still in use and replace with a newly designed blower cover, without additional foam, for noise reduction purposes.

Worldwide, the Carina ventilator was distributed to customers by Dräger Sales and Service entities. The Carina ventilator was manufactured from November 1, 2006, through November 30, 2019.

To determine the long-term stability of the polyether polyurethane (PE-PUR) foam used for sound insulation in Carina ventilators, Dräger subjected devices of different ages to biocompatibility tests. For Carina ventilators operated for periods of up to 15 years, no age-related degradation or decay products associated with degradation were found in those standard tests. However, certain standard tests conducted by Dräger measured concentrations of 1,3-Dichloropropan- 2-ol above the acceptable uptake level during continuous use (>30 days) in pediatric patients. Dräger’s investigations determined that a setting of higher minute volumes leads to lower concentrations in the breathing air. At a minute volume greater than 3.6 l/min, the measured concentrations were in the acceptable range for continuous use in adult patients. 1,3-Dichloropropan-2-ol is a constituent of the polyurethane foam, which was not discovered in the breathing gas during previous biocompatibility tests conducted within the framework of product approvals and modifications. Potential Patient Impact.

In literature, 1,3-Dichloropropan-2-ol is considered to be acutely toxic and a potential carcinogen. Potential risks of chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. There have been no reports of death as a result of such exposure. These issues may result in serious injury, which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment. To date, Dräger has not received any reported symptoms of an acute toxic reaction, nor any other complaints relating to this issue via our market surveillance.

Company name: Drägerwerk AG & Co. KGaA
Brand name: Dräger
Product recalled: Carina Sub-Acute Care Ventilators
Reason of the recall: Product Safety/Potential Foreign Material
FDA Recall date: August 04, 2023

Source: www.fda.gov

upstream occlusion alarms following the software upgrades. Baxter will be working with customers to revert the software on all affected pumps to the previous software version. The upgraded software installed on Spectrum V8 and Spectrum IQ infusion pumps may cause an alarm for an upstream occlusion when there is no actual upstream occlusion present. This false alarm may lead to an interruption or delay of therapy. An interruption or delay of therapy may cause serious adverse health consequences in patients who are receiving life-sustaining medications. Baxter has received three reports of serious injury potentially associated with this issue.

Baxter representatives are contacting all affected customers to schedule the software reversion. Until the reversion is completed, false upstream occlusion alarms can occur on impacted pumps at a higher rate. Customers can continue to use Spectrum V8 and Spectrum IQ infusion pumps by following on-screen instructions or referencing the Preparing the Pump and IV Sets and Programming the Pump sections and upstream occlusion alarm troubleshooting in the Alarms section of the Operator’s Manual. If a customer is unable to resolve an upstream occlusion alarm, they should unload and reload the set.

This Urgent Medical Device Correction applies to SIGMA Spectrum Infusion System (V8 Platform) with product code 35700BAX2 and software version v8.01.01 and Spectrum IQ Infusion System with Dose IQ Safety Software with product code 3570009 and software version v9.02.01. Spectrum V8 and Spectrum IQ infusion pumps are distributed in the United States, Puerto Rico, Canada and certain Caribbean islands. Only customers in the U.S. and Puerto Rico are affected by this Correction.

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: SIGMA Spectrum and Spectrum IQ
Product recalled: Infusion pumps
Reason of the recall: Due to an increase in reported false upstream occlusion alarms following the software upgrades.
FDA Recall date: July 31, 2023

Source: www.fda.gov