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Terminated

TMJ Arthroscopy Drape, 85''x 96''

FDA Recall Z-1071-2022 · Posted None

Recalling FirmMicrotek Medical Inc.
Recall StatusTerminated
Product CodePUI
Date Initiated2022-04-08
Date Terminated2024-06-05
Product Quantity12 cases (120 drapes)

Reason for Recall

Latex content in product was labeled incorrectly as latex free.

Firm Action

All consignees were contacted on 04/08/2022 via email. Consignees should read the recall instruction, examine their inventory, and quarantine the lots listed in the letter. The consignees should also complete the enclosed response form and email it to [email protected]. If the consignee has further distributed the product, they should identify and notify their customers of the recall.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed nationwide to CO, PA, and WI.

Official Source

View FDA Recall →

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

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