Recall Z-1793-2022 ยท FRC Indicator, Biological Sterilization Process
Mckesson Medical-Surgical Inc. Corporate Office
a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/4 Inch Model Number: PCC006. c. STERIS CORP VERIFY Verify Sterilization Biological Indicator Pack Steam Model Number: S3069. d. STERIS CORP Celerity Celerity Sterilization Biological Indicator Vi
| Date | Sep 26, 2022 (initiated May 25, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Environmental control |
| Action | Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 sedgwick@sedgwick.com. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to pr |
| Quantity | a. 10 bx, b. 20 bx, c. 7 bx, d. 6 bx, e. 18 bx, f. 1 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070461 | VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 STERIS Corporation, Jul 17, 2007 |
| K152630 | VERIFY STEAM Integrating Indicator STERIS Corporation, May 12, 2016 |
| K171504 | VERIFY Assert VH2O2 Self-Contained Biological Indicator STERIS Corporation, Aug 22, 2017 |
| K173626 | Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles STERIS Corporation, Feb 21, 2018 |
| K854902 | SURGICOT STEAM TEST PACK Surgicot, Inc., May 20, 1986 |