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Terminated

COVENA PICC Sleeve

FDA Recall Z-0187-2022 · Posted None

Recalling FirmQueen Comfort Products lLC
Recall StatusTerminated
Product CodeFMQ
Date Initiated2021-08-18
Date Terminated2024-05-06
Product Quantity91 units

Reason for Recall

Marketed without FDA clearance

Firm Action

The firm notified their consignees of the recall through a distributor electronic portal on 08/17/2021. The firm requested return of the product.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

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

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