Recall Z-1792-2022— Mckesson Medical-Surgical Inc. Corporate Office

Name: FDA recall Z-1792-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-25

Class III · Ongoing

Class III FDA medical device recall by Mckesson Medical-Surgical Inc. Corporate Office, initiated 2022-05-25. It names 2 FDA 510(k) clearances: K020409, K890759. 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..

Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Classification: Class III
Status: Ongoing
Initiated: 2022-05-25
Firm location: Richmond, VA, United States

510(k) clearances named in this recall

2 on FDA's record

K020409 — STEAMPLUS STERILIZATION TESTSpsmedical Supply Corp.·cleared 2002-07-18
K890759 — STRIP, STERILIZATION INDICATOR; STEAMSpsmedical Supply Corp.·cleared 1989-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.