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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1790-2022 |
| Event ID | 90731 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | a. 60 b. 1 box |
| Recall 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. |
| Device Classification | 20221005 |
| Device Code Info | GTIN: a. 00732224720074; 50732224720079; 10732224720071. b. 00732224720081; 50732224720086; 10732224720088. |
| Center Classification Date | 20220926 |
| Recall Initiation Date | 20220525 |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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