Z-1792-2022 Class III Ongoing
FDA device recall Z-1792-2022 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on May 25, 2022 and is designated Class III. 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. The recall status is ongoing. Affected quantity: a. 1 box, b. 19 cases.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 5, 2022
- Initiation Date
- May 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a. 1 box, b. 19 cases.
Product 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 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 Pattern
US Nationwide distribution.
Code Information
GTIN: a. 00732224710174; 10732224710171. b. 00732224710433; 10732224710430.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1792-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026