FDA Device recall Z-0090-2023
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Exten…
- FDA Device
- Class II
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II 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 Exten… by B Braun Medical, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0090-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-15 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | B Braun Medical |
| Distribution | US |
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
Reason
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.
Identifiers
| code_info | UDI-DI (GTIN): 04046964185670 Lots/Expiration Dates 0061627491 31 May 2023 0061637554 31 Jul 2023 0061656218 31 Dec 20…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0090-2023%22
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