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Recall Observatory FDA recall evidence

Device product

MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430AZ

Z-1493-2022

June 29, 2022

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 90558
Status
Ongoing
Classification
Class II
Quantity
6119500 wipes
Official record key
device-enforcement:Z-1493-2022

Official wording

Reason: stability failure

Code information: Lot numbers 0546 through 3126 (this represents all lot numbers)

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    stability failure