Recall Z-0434-2014 ยท FRG Wrap, Sterilization
Advanced Sterilization Products
STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficie
| Date | Dec 3, 2013 (initiated Oct 3, 2013) |
| Status | Terminated |
| Reason | Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed containers. |
| Root cause | Device Design |
| Action | Advanced Sterilization Products (ASP) sent a Urgent Medical Device Field Safety Notification letter dated October 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers who received the SteriTite Containers. Customers were instructed to: Provide this notice to anyone in your facility that needs to be informed. Maintain a copy of this notice with the affected product. Maintain awareness of this notice. Customers are instructed to contact Stericycle at (888) 912-7092 for additional questions related to the recall le |
| Quantity | 267 units total (252 units in US) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Vietnam, Thailand, Malaysia, China, Korea (South), Mexico, Spain, Singapore, Hong Kong and Portugal. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023614 | STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM Case Medical, Inc., Apr 7, 2003 |
| K030853 | STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI Case Medical, Inc., Mar 21, 2003 |
| K080558 | STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS Case Medical, Inc., Dec 5, 2008 |