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
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling SporView Culture Set SporView Sterilization Biological Indicator Kits (Model CS-020) used for steam, EO gas, dry heat, and chemical vapor sterilization. The recall affects all lots received between June 1, 2021 and September 30, 2021 that were distributed nationwide. The kits may have been exposed to higher temperatures during storage at the facility between June and August 2021, which could have reduced their effectiveness as sterilization indicators.
The recall involves a total of 61 units. Affected products can be identified by their GTINs: 00732224720074, 50732224720079, 10732224720071, 00732224720081, 50732224720086, and 10732224720088. The recall notice does not specify a remedy or recommended action for consumers who have received these products.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide distribution. Quantity: a. 60 b. 1 box Lot/code info: GTIN: a. 00732224720074; 50732224720079; 10732224720071. b. 00732224720081; 50732224720086; 10732224720088.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.