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Recall Observatory FDA recall evidence

Device product

Cooper Surgical PREFILTER, SMOKE EVAC (10/BX)CPRSRG Model Number: 52560.

Z-1795-2022

May 25, 2022

Class III

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Event
Event 90731
Status
Ongoing
Classification
Class III
Quantity
9 boxes
Official record key
device-enforcement:Z-1795-2022

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: 20845854053178; 30845854053175 BX; 00845854053174 EA.

Distribution pattern: US Nationwide distribution.

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.