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Recall Observatory FDA recall evidence

Device product

Michels Transport Medium, 20ML Prefilled Cont

Z-0656-2022

December 01, 2021

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 89164
Status
Terminated
Classification
Class II
Quantity
2,816 units (22 cases, 128 per case)
Official record key
device-enforcement:Z-0656-2022

Official wording

Reason: Product stored incorrectly in temperature controlled setting instead of refrigeration.

Code information: Model Number: AZSES3270, all lots with expiration date range of 08/28/2021 through 09/03/2023

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product stored incorrectly in temperature controlled setting instead of refrigeration.