FDA Device recall Z-1792-2022
a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS ME…
- FDA Device
- Class III
- ongoing
- Published 2022-10-05
On 2022-10-05 the FDA classified a Class III recall of a. SPS MEDICAL SUPPLY Steam Indicator Strip SPSmedical Sterilization Chemical Indicator Strip Steam 4 Inch Model Number: SIS-250. b. SPS ME… by Mckesson Medical Surgical Corporate Office, citing facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1792-2022 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2022-05-25 |
| Published | 2022-10-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | US |
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.
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.
Identifiers
| code_info | GTIN: a. 00732224710174; 10732224710171. b. 00732224710433; 10732224710430. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1792-2022%22
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