Reported Oct 26, 2022 · Ongoing

Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended…

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?

Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector.

Lot codes and dates: UDI-DI (GTIN)04046964540943 Lots/Expiration Dates
61705083
31-Oct-22
61705124
31-Oct-22
61706055
31-Oct-22
61714103
31-Dec-22
61719696
31-Jan-23
61732456
31-Mar-23
61736580
31-May-23
61739427
31-May-23
61744671
31-Jul-23
61747367
31-Aug-23
61750206
31-Aug-23
61752658
30-Sep-23
61761422
30-Nov-23
61776447
30-Apr-24
61780880
30-Apr-24
61802320
30-Sep-24
61806067
31-Oct-24
61807459
31-Oct-24
61822282
28-Feb-25
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 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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