Device product
Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
Z-0731-2016
Product summary
- Event
- Event 72946
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,695
- Official record key
device-enforcement:Z-0731-2016
Official wording
Reason: All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.
Code information: All Lots
Distribution pattern: Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.
Derived failure modes
-
Unknown
All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.