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Terminated

Kit: Central Line Dres Change 20/Cs

FDA Recall Z-0147-2022 · Posted None

Recalling FirmMedical Action Industries, Inc. 306
Recall StatusTerminated
Product CodePEZ
Date Initiated2021-09-08
Date Terminated2023-10-13
Product Quantity42 cases

Reason for Recall

The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.

Firm Action

A customer email was sent to the impacted distributor dated 09/16/2021. The distributor was notified of the recall issue and instructed to inventory and segregate affected product. Warning labels were provided and are to be affixed to the affected kits. Relabeling should be conducted in a manner that does not allow other pertinent labeling information to be covered up. The distributor was also notified that the recall should be carried out to the end user level.

Root Cause

Process control

Distribution Pattern

Distribution to a single US distributor in Michigan

Official Source

View FDA Recall →

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

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