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Mckesson Medical-Surgical Inc. Corporate Office Recall 90731

Description: 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

Mckesson Medical-Surgical Inc. Corporate Office Recall 90731 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1790-2022
Event ID90731
Event Descriptiona. 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
Product TypeDevices
DistributionUS Nationwide distribution.
Quantitya. 60 b. 1 box
Recall ReasonFacility 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.
Device Classification20221005
Device Code InfoGTIN: a. 00732224720074; 50732224720079; 10732224720071. b. 00732224720081; 50732224720086; 10732224720088.
Center Classification Date20220926
Recall Initiation Date20220525
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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