Recall Z-2417-2012 ยท MLR Sterilizer, Chemical
Steris Corporation
Verify Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for critical cycle information to be recorded. The card is laminated inside a thin clear plastic enclosure. The enclosure has tw
| Date | Sep 20, 2012 (initiated Jul 3, 2012) |
| Status | Terminated |
| Reason | STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications. Specifically, test cards have resulted in false fail results when sterilizer performance is within acceptable ranges. |
| Root cause | Nonconforming Material/Component |
| Action | Steris Corporation sent a Urgent Voluntary Recall Notice dated July 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to examine their inventory and compare the lot numbers printed on the box with the listed lots. If they have products from the affected lot numbers to contact STERIS Customer Service for account credit. After notifying STERIS of the amount of recalled product on hand they are to immediately destroy the product. Distributors are to also notify their customers of th |
| Quantity | 629 cards |
| Distribution | Worldwide Distribution--USA (nationwide) including the states of AL, CA, CO, CT, FL, GA, IA, IN, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK,OR, PA, RI, SC, TX, UT, VA, WA, WI, WV and WY. and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K897045 | BOWIE-DICK TEST CARD CATALOG NUMBER 008018 Edward Weck, Inc., Feb 15, 1990 |