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Recall Observatory FDA recall evidence

Device product

Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm, Sterile Model Number: 40825

Z-1593-2022

May 25, 2022

Class II

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Event
Event 90336
Status
Ongoing
Classification
Class II
Quantity
2 Box
Official record key
device-enforcement:Z-1593-2022

Official wording

Reason: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Code information: GTIN: 00886158012108; 30886158012109

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.