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Oscor Destino Twist & Guidestar - recalled due to potential detachment, USA

2 years ago

United States

Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal on the proximal end of the device handle detaching during use.

RISK STATEMENT: The Destino Twist 14T Model DST1405525 & Guidestar 14F Model D141103 detachment of the hub cap and seal could lead to bleeding at the proximal end of the device and/or air embolism for the patient during intracardiac, renal or other peripheral placements procedures.

Oscor Inc. has reported two (2) Medical Device Reports to the FDA related to detachment of hub cap and seal on the proximal end of the device handle. The recall is limited to the two model numbers and lot numbers outlined above. There are no other recalls associated with this product.

PRODUCT INFORMATION: The product is steerable guiding sheath intended for the introduction of diagnostic and therapeutic devices into the human vascular, including but not limited to intracardiac, renal or other peripheral placements; it cannot be use for neural placements. The product is provided sterile, one unit per pouch / tray for details and can be identified on the printed labeling with the information below (1, 2, and 3).

The affected Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 were distributed Worldwide to distributors and hospitals from June 8, 2021 to November 30, 2021.

Recalled Product Impacted (1)

- Destino Twist 14F (DST1405525). UDI Number: 885672011123. Lot Number: PQOC13475. Expiration Date 10-01-2021. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14073. Expiration Date 11-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14072. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14071. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13834. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13828. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13827. Expiration Date 08-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12995. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12632. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12633. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12345. Expiration Date 06-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12330. Expiration Date 06-01-2025. Packaging State Type: Sterile.

Destino 14F Twist Model (2)

Product: Destino Twist 14F
GTIN (Unit): 00885672011123
Model: DST1405525
Sheath & Dilator: S55CM D73CM
French Size: 14F
Quantity: 6 Units

Guidestar 14F - Model (3)

Product: Guidestar 14F
GTIN (Unit): 00885672010911
Model: D141103
Sheath & Dilator: S71CM D89CM
French Size: 14F
Quantity: 543 Units

Company name: Oscor Inc.
Brand name: Oscor
Recalled: Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 steerable guiding sheath
Reason of the recall: Hub cap and seal on the proximal end of the device handle may detach during use
FDA Recall date: January 12, 2022

Check the full recall details on fda.gov

Source: FDA

303


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Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can... See More result in an over-potent dosing regimen. The affected Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL lots were distributed Nationwide in the USA directly to Wholesalers and Distributors. The Lots were distributed between 11/09/2023 and 2/20/2024. To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Risk Statement: Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle. Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.

The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency. The error occurred during the manual bottle filling stage of manufacturing.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile.

The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label. The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL.
- Pack Size: 80 mL, Expiration Date: 09/2025, Lot: 22613003A, NDC No.: 69238-2261-3.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613004A, NDC No.: 69238-2261-7.
- Pack Size: 150 mL, Expiration Date: 09/2025, Lot: 22613005A, NDC No.: 69238-2261-7.
- Pack Size: 300 mL, Expiration Date: 09/2025, Lot: 22613005B, NDC No.: 69238-2261-5.

Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Retailers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots.

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: Amneal Pharmaceuticals, LLC.
Brand name: Amneal
Product recalled: Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL
Reason of the recall: Super potent due to bottles being overfilled
FDA Recall date: March 27, 2024

Source: fda.gov
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InfuTronix, LLC has announced a voluntary recall of the Nimbus Ambulatory Infusion Pump System, including Nimbus II PainPro, Nimbus II Flex, Nimbus II Plus, Nimbus II EpiD and Nimbus II EMS from the US Market due to a high number (3698) of customer complaints related to the... See More Nimbus Infusion Pump systems dated May 2019 to August 2023.

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These product issues were identified through the InfuTronix post-market surveillance system and evaluated through the InfuTronix Corrective Action/Preventive Action (CAPA) system. InfuTronix has determined that the best corrective and preventive action to address the identified product issues and potential outcomes is a redesign of the Nimbus Infusion Pump system. The redesign of the system will allow InfuTronix to improve several aspects of the product including mechanics, electronics, software, and housing design as well as aspects of the administration set. Given the number of anticipated design improvements and the extensive requirement for design, verification, and validation, InfuTronix believes a new premarket notification(s) and clearance from FDA may be required. As such, InfuTronix is seeking to remove the system from the market while these improvements and design changes are being made and a new clearance(s) is obtained.

A health hazard evaluation (HHE) was performed by an independent physician to evaluate routine post-market complaint failure modes associated with the Nimbus family of infusion pumps. The HHE determined that the common device failure modes pose a low risk to users.

The Nimbus Infusion Pump system has been distributed throughout the United States since October 17, 2014 until February 21, 2024. It has never been distributed internationally. Affected devices have the following Unique Device Identification numbers associated with them:
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- Nimbus II PainPRO 00817170020086
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- Nimbus II Plus 00817170020161
- Nimbus II EpiD 00817170020376
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Users may continue to use the Nimbus Infusion Pump system and associated infusion sets during this removal process. Users should be aware of the signs indicating a potential issue with the pump (How to recognize that a device may fail):

- Battery – The infusion pump will brown out (fail-safe). The user will see that the pump has shut off. Additionally, the LED screen may flicker prior to failure, indicating a potential battery issue.
- Upstream Occlusion - Auditory and visual occlusion alarm alerts the user of the occlusion.
- System Error - Auditory and visual system error alarm will alert the user.
- Drug Product Egress – The user may notice leaking drug from the pump pouch or infusion set or feel wetness from the drug product.
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- Due to the potential ambulatory use of the pump, patients may carry the drug product dispensing pouch in a carrying pack. Patients should be educated that impeding the tubing set or placing pressure on the device (leaning against it, sitting on it) may cause the device to malfunction.
- HCPs are encouraged to educate patients on potential drug leakage and establish appropriate containment protocols for users to follow.

HCPs should ensure users are educated to recognize audio and visual alarms and inspect their device for damage. Any difficulties or abnormalities noted with the pump or accessories should result in immediate discontinued use of the pump and notification to the HCP. Customers of InfuTronix who have Nimbus Infusion Pumps and associated infusion sets in their possession should contact InfuTronix customer service, where they will be instructed on the Return Material Authorization (RMA) process to be followed for returning both the Nimbus Infusion Pumps and associated infusion sets.

Customers who purchase the Nimbus Infusion Pump and/or associated infusion sets from a distributor should contact their distributor directly and receive instructions on the RMA process to be followed. As the device will not be available or supported after June 20, 2024, InfuTronix encourages the healthcare provider to seek alternative methods of drug product infusion appropriate for their patient’s needs, based on their medical expertise, at the earliest possible opportunity. InfuTronix is removing the Nimbus Infusion Pump Systems from the market.

The products will no longer be supported by InfuTronix for either Nimbus Infusion Pumps or related infusion sets beyond June 20, 2024. To return Nimbus products customers should follow the instructions provided in the Medical Device Removal letter that was sent by InfuTronix, contact InfuTronix customer service or their local distributor.

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Brand name: Nimbus
Product recalled: Nimbus Pump System
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FDA Recall date: March 20, 2024

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2- Updated Warning:
Magnets are used in the mask and headgear clips with a field strength of 380mT. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 16 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This applies to you or anyone in close physical contact with your mask.

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