ULTRASITE US04TL Smallbore T-Port Extension Set — Class II medical device recall Z-0090-2023
Ongoing recall by B. Braun Medical, Inc., reported 2022-10-26, distributed nationwide. The extension set has a high probability of failure which could lead to possible leakage or detachment at the
| Recall number | Z-0090-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2022-09-15 |
| Classified | 2022-10-14 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, SA |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 04046964185670 |
| Lot numbers | 0061627491, 0061637554, 0061656218, 0061659612, 0061662459, 0061667312, 0061671264, 0061712679, 0061716017, 0061718208, 0061719862, 0061762008, 0061765391, 0061791921 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0090-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.