Reported Nov 15, 2023 · Ongoing
SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
B. Braun Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B. Braun Medical, Inc. · 901 Marcon Blvd · Allentown, PA · 18109-9512
Is this the product you have?
SA3000 VENTED MICRO SPIKE ADAPTERREF No. 418121for intravenous use
- Lot codes and dates
- UDI-DI4046964183454 Lots 0061746019 0061755023
- Amount recalled
- 17,100 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
This product could cause temporary or reversible health problems — stop using it.
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