—#196059

Product

ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K955585
Affected lot / code info: UDI-DI (GTIN): 04046964185670 Lots/Expiration Dates 0061627491 31 May 2023 0061637554 31 Jul 2023 0061656218 31 Dec 2023 0061659612 31 Jan 2024 0061662459 31 Jan 2024 0061667312 29 Feb 2024 0061671264 31 Mar 2024 0061712679 31 Dec 2024 0061716017 31 Jan 2025 0061718208 31 Jan 2025 0061719862 31 Jan 2025 0061762008 31 Dec 2025 0061765391 31 Jan 2026 0061791921 31 JUL 2026

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Distribution US nationwide, Canada and Saudi Arabia.

Timeline

Recall initiated: 2022-09-15
Posted by FDA: 2022-10-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196059. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.