regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
FDA device recall Z-0411-2022 · posted 2021-12-22 · Terminated
Recall details
- Recalling firm
- ROi CPS LLC
- Reason for recall
- The kit contains a non-sterile needle.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MLS
- Quantity affected
- 40 kits
- Distribution
- Distribution was made to Missouri. There was no foreign/military/government distribution.
- Date initiated
- 2021-11-04
- Date posted
- 2021-12-22
- Date terminated
- 2023-08-07
- Location
- Republic, MO
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