Recall archive / FDA device enforcement
Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intend... — FDA record Z-0091-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 15, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 354,200 US; 1,800 OUS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0091-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution US nationwide, Canada and Saudi Arabia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 26, 2022
- Recall initiation date
- Sep 15, 2022
- Center classification date
- Oct 14, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.