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Terminated

Michels Transport Medium, 20ML Prefilled Cont

FDA Recall Z-0656-2022 · Posted None

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusTerminated
Product CodeNNI
Date Initiated2021-12-01
Date Terminated2023-02-13
Product Quantity2,816 units (22 cases, 128 per case)

Reason for Recall

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Firm Action

Medline notified customer through first class mail on about 12/01/2021, via letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock and quarantine affected devices, return the completed provided response form indicating affected product on hand and destroyed, and to notify customers if affected product was further distributed. An amended customer letter was sent on 12/17/2021. The explanation of the issue was updated. Instructions remained the same.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of Colorado, Florida, New York, North Carolina, and Texas.

Official Source

View FDA Recall →

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

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