CLASS II ONGOING Device recall · Reported 26 Oct 2022 · FDA Enforcement Report
Ultrasite US04TL Smallbore T-Port Extension Set, Product recalled
B. Braun Medical is recalling Ultrasite US04TL Smallbore T-Port Extension Set, distributed nationwide in the US. The recall was initiated on 15 Sep 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0090-2023
- FDA event ID
- 90850
- Recalling firm
- B. Braun Medical, Allentown, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Sep 2022
- FDA classified
- 14 Oct 2022
- Reported
- 26 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Syringes & Needles
Timeline
| 15 Sep 2022 | Recall initiated by company | |
| 14 Oct 2022 | Classified by FDA | +29 days |
| 26 Oct 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Distribution US nationwide, Canada and Saudi Arabia.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Distribution US nationwide, Canada and Saudi Arabia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 90850This product is part of a recall event; the main page for the event is Caresite Smallbore Ext Set T-port, Product recalled by B. Braun Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Caresite Smallbore Ext Set T-port, Product recalled by B. Braun Medical | B. Braun Medical | Packaging Defects | Nationwide | |
| CLASS II | Extension Set, EXT SET W/Caresite, Product recalled by B. Braun Medical | B. Braun Medical | Packaging Defects | Nationwide |
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