Z-0090-2023Class II

ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide...

Name: Z-0090-2023 ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide...
Creator: B. Braun Medical, Inc.
Published: 2022-09-15
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2022-09-15 / Open, Classified / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of 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 on 2022-09-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0090-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-15
Posted: 2022-10-14
Recalling firm: B Braun Medical Inc
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
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 354,200 US; 1,800 OUS
Distribution: Distribution US nationwide, Canada and Saudi Arabia.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0090-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0090-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-14
Z-0091-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-14
Z-0092-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-14

Product code FPA

K955585Class IIV2 Injection SiteB.Braun Medical, Inc. / cleared 1996-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)