Recall Z-0390-2011 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Sorin Group USA, Inc.
Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504500, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
| Date | Nov 15, 2010 (initiated Oct 7, 2010) |
| Status | Terminated |
| Reason | Defective product packaging may compromise product sterility. |
| Root cause | Packaging process control |
| Action | Sorin Group sent an "URGENT: FIELD SAFETY NOTICE" letter dated October 7, 2010, to all customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to check all affected inventory to exam for holes. Any damaged products were to be returned to Sorin. If no damage was found, product could be used. The customers were also instructed to contact Sorin Cardiopulmonary Customer Service at 1-800-650-2623 to return product and receive replacement; they were to share this information with all personnel who may use this product; and to comple |
| Quantity | 4 |
| Distribution | Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K881330 | COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK Cobe Laboratories, Inc., Jun 10, 1988 |