Reported Oct 26, 2022 · Ongoing
CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve…
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?
- CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood.
- Lot codes and dates
- UDI-DI (GTIN)04046964298691 Lots/Expiration Dates
6176221515-Dec-236176279122-Jan-246176736926-Feb-24617796257-Jun-246179189511-Aug-24618060474-Nov-24
- UDI-DI (GTIN)04046964298691 Lots/Expiration Dates
- Amount recalled
- 354,200 US; 1,800 OUS
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The extension set has a high probability of potential 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.
This product could cause temporary or reversible health problems — stop using it.
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