Device product
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Z-0411-2022
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 89078
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 kits
- Official record key
device-enforcement:Z-0411-2022
Official wording
Reason: The kit contains a non-sterile needle.
Code information: Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.
Distribution pattern: Distribution was made to Missouri. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
The kit contains a non-sterile needle.