PlainRecalls
FDA Devices Low Class III Ongoing

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

Reported: October 5, 2022 Initiated: May 25, 2022 #Z-1790-2022

Product 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

Reason for Recall

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.

Details

Units Affected
a. 60 b. 1 box
Distribution
US Nationwide distribution.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
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. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: a. 60 b. 1 box.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 5, 2022. Severity: Low. Recall number: Z-1790-2022.