Recall Z-0411-2022
ROi CPS LLC · initiated November 4, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Codes / lots: Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074.
Reason for recall
The kit contains a non-sterile needle.
FDA-determined 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.
Details
- Recall number
- Z-0411-2022
- Initiated
- November 4, 2021
- Posted by FDA
- December 22, 2021
- Terminated
- August 7, 2023
- Product code
- MLS – Labor And Delivery Kit
- Quantity
- 40 kits
- Distribution
- Distribution was made to Missouri. There was no foreign/military/government distribution.
- Recalling firm
- ROi CPS LLC, Republic, MO