Recall Z-1096-2010 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Sorin Group USA, Inc.
Smart Perfusion Pack, REF: 088504500, Sterile EO, 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 | Mar 12, 2010 (initiated Dec 30, 2009) |
| Status | Terminated |
| Reason | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. |
| Root cause | Packaging process control |
| Action | Customers were notified by letter on December 30, 2009 and asked to examine all inventory for seal voids and arrange for return if any were found defective. Examination instructions were included. The two distributors were given the same instructions and were told to share all the information with any of their customers. |
| Quantity | 17 units |
| Distribution | AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI. |
| 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 |