regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
This recall has been terminated (originally issued December 22, 2021).
- Company
- Roi Cps Llc
- Recall Initiated
- November 4, 2021
- Posted
- December 22, 2021
- Terminated
- August 7, 2023
- Recall Number
- Z-0411-2022
- Quantity
- 40 kits
- Firm Location
- Republic, MO
- Official Source
- View on FDA website ↗
Reason for Recall
The kit contains a non-sterile needle.
Distribution
Distribution was made to Missouri. There was no foreign/military/government distribution.
Lot / Code Info
Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.
Root Cause
Process control
Action Taken
The firm issued a letter dated 11/4/2021 via email on 11/4/2021 explaining the reason for recall, the health risk involved, and the actions to be taken by the customer. The customer was requested to check their inventory for the affected kits and immediately quarantine them without further distribution. The attached reply form was to be completed so that return of the affected kits could be arranged. If the kits were further distributed, the customer was requested to notify their customers.