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Recall Observatory FDA recall evidence

Device product

a. SporView Culture Set SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-020 b. SPORVIEW CULTURE SET SporView Sterilization Biological Indicator Kit Steam / EO Gas / Dry Heat / Chemical Vapor Model Number: CS-100

Z-1790-2022

May 25, 2022

Class III

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Event
Event 90731
Status
Ongoing
Classification
Class III
Quantity
a. 60 b. 1 box
Official record key
device-enforcement:Z-1790-2022

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: a. 00732224720074; 50732224720079; 10732224720071. b. 00732224720081; 50732224720086; 10732224720088.

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.