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Terminated

KWIK-STIK" plus: Clostridium perfringens

FDA Recall Z-1125-2022 · Posted None

Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeJTR
Date Initiated2022-05-06
Date Terminated2024-01-16
Product Quantity8 units

Reason for Recall

Labeling error.

Firm Action

The firm issued a recall notification to the consignees beginning on 05/06/2022 via email. The letter informs the consignee to inspect inventory, review lab procedures, use or discard affected product depending on lab procedures, and complete the response form.

Root Cause

Labeling mix-ups

Distribution Pattern

Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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