a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b.
FDA device recall Z-1793-2022 · posted 2022-09-26 · Open, Classified
Recall details
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- 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.
- Action taken
- 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 prevent possible patient harm. Please complete and return the enclosed response form as soon as possible even if you do not have any product on hand. Customers should contact Sedgwick directly by phone at 1-888-943-2401 to return the recalled products or if they have additional questions regarding this notification. Representatives are available Monday Friday, 8:00 am 5:00 pm PT
- Root cause
- Environmental control
- Status
- Open, Classified
- Product code
- FRC
- Quantity affected
- a. 10 bx, b. 20 bx, c. 7 bx, d. 6 bx, e. 18 bx, f. 1
- Distribution
- US Nationwide distribution.
- Date initiated
- 2022-05-25
- Date posted
- 2022-09-26
- Location
- Richmond, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles (K173626) | STERIS Corporation | 2018-02-21 |
| VERIFY Assert VH2O2 Self-Contained Biological Indicator (K171504) | STERIS Corporation | 2017-08-22 |
| VERIFY STEAM Integrating Indicator (K152630) | STERIS Corporation | 2016-05-12 |
| VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 (K070461) | STERIS Corporation | 2007-07-17 |
| SURGICOT STEAM TEST PACK (K854902) | Surgicot, Inc. | 1986-05-20 |