Extension Set recallZ-0091-2023 · B. Braun Medical, Inc. · initiated Sep 15, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B. Braun Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-0091-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 15, 2022
- Posted by the FDA
- Oct 14, 2022
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 354,200 US; 1,800 OUS
- Product code
- FPA
- FDA submissions
- K942988, K954123, K083723
- Distribution
- Distribution US nationwide, Canada and Saudi Arabia.
Product description
Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 04046964540943 Lots/Expiration Dates 61705083 31-Oct-22 61705124 31-Oct-22 61706055 31-Oct-22 61714103 31-Dec-22 61719696 31-Jan-23 61732456 31-Mar-23 61736580 31-May-23 61739427 31-May-23 61744671 31-Jul-23 61747367 31-Aug-23 61750206 31-Aug-23 61752658 30-Sep-23 61761422 30-Nov-23 61776447 30-Apr-24 61780880 30-Apr-24 61802320 30-Sep-24 61806067 31-Oct-24 61807459 31-Oct-24 61822282 28-Feb-25
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Extension Set 470169B. Braun Medical Inc. · Set, administration, intravascular1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90850).
- Z-0090-2023 · Open, ClassifiedULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
- Z-0092-2023 · Open, ClassifiedCARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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