Device product
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.
Z-1792-2022
Product summary
- Event
- Event 90731
- Status
- Ongoing
- Classification
- Class III
- Quantity
- a. 1 box, b. 19 cases.
- Official record key
device-enforcement:Z-1792-2022
Official wording
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 information: GTIN: a. 00732224710174; 10732224710171. b. 00732224710433; 10732224710430.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.