Device product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100, c) 25 pack, REF H938690025
Z-1575-2022
Product summary
- Event
- Event 90658
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 602340 units
- Official record key
device-enforcement:Z-1575-2022
Official wording
Reason: There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
Code information: a) REF H93866025, UDI 00085412478845, ALL LOTS; b) REF H93866100, UDI 00085412478852, ALL LOTS; c) REF H938690025, UDI 00085412479941, ALL LOTS
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.