Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended

FDA device recall Z-0091-2023 · posted 2022-10-14 · Open, Classified

Recall details

Recalling firm: B. Braun Medical, Inc.
Reason for recall: The extension set has a high probability of failure which could lead to possible leakage or detachment at the device's bonded joint during use. The issue may result in delay of therapy, increased risk of bloodstream infections (BSI), and may expose both patients and healthcare workers to hazardous medications. Depending on the nature of the leak and type of infusion, there is also the potential for life-threatening situations to occur including air embolization or hypovolemia.
Action taken: On September 15, 2022, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were instructed to cease use and quarantine the product subject to recall. Once customers have returned the completed acknowledgement form to B. Braun Medical Inc., a Customer Support representative will contact the customer with instructions on returning impacted cases. The firm will provide credit and/or replacement of the product based on the customer's needs. For questions, please contact BBMI's Postmarket Surveillance Department at 1-833-425-1464.
Root cause: Process design
Status: Open, Classified
Product code: FPA
Quantity affected: 354,200 US; 1,800 OUS
Distribution: Distribution US nationwide, Canada and Saudi Arabia.
Date initiated: 2022-09-15
Date posted: 2022-10-14
Location: Allentown, PA

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