Device product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100
Z-1577-2022
Product summary
- Event
- Event 90658
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10140 units
- Official record key
device-enforcement:Z-1577-2022
Official wording
Reason: There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
Code information: REF H938671100, UDI 00085412479750
Distribution pattern: Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.
Derived failure modes
-
Unknown
There is a potential of the packaging not maintaining a sterile barrier for the tip caps.