FDA Enforcement
Class III
Ongoing
a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL SUPPLY SteamPlus Sterilization Integrator Sterilization Steam Plus Monitor Model Number: SSI-1000.
Recall: Z-1792-2022
·
Reported October 5, 2022
Enforcement
- Recall Number
- Z-1792-2022
- Event ID
- 90731
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- October 5, 2022
- Initiation Date
- May 25, 2022
- Classification Date
- September 26, 2022
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, 23233, United States
Description
a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS MEDICAL SUPPLY SteamPlus Sterilization Integrator Sterilization Steam Plus Monitor Model Number: SSI-1000.
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 Info
GTIN: a. 00732224710174; 10732224710171. b. 00732224710433; 10732224710430.
Distribution
US Nationwide distribution.
Quantity
a. 1 box, b. 19 cases.