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Terminated

regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

FDA Recall Z-0411-2022 · Posted 2021-12-22

Recalling FirmROi CPS LLC
Recall StatusTerminated
Product CodeMLS
Date Initiated2021-11-04
Date Terminated2023-08-07
Product Quantity40 kits

Reason for Recall

The kit contains a non-sterile needle.

Firm Action

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

Distribution Pattern

Distribution was made to Missouri. There was no foreign/military/government distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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