Device product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
Z-0948-2022
Product summary
- Event
- Event 89682
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,500 DISCPACs (100/DISCPAC).
- Official record key
device-enforcement:Z-0948-2022
Official wording
Reason: Product is mislabeled as self-righting Luer slip tip caps, yellow.
Code information: Lot numbers 60268365, 60268609, 60268610, exp. date 10/31/2023; UDI 0085412478852.
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of FL, GA, IL, IN, MO, PA, TX, and VA. The countries of Canada, Austria, Germany, Netherlands, Qatar, Saudi Arabia, and Spain.
Derived failure modes
-
Labeling or packaging
mislabeled