Recall Z-2074-2010 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Sorin Group USA, Inc.
B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5.
| Date | Jul 22, 2010 (initiated Jun 18, 2010) |
| Status | Terminated |
| Reason | Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories covered the new HLM S5 system. The three accessories were not cleared for use with the HLM C5. |
| Root cause | PMA |
| Action | The two customers who had received the suspect device accessories were identified and were contacted by letter on 6/18/2010. They were told to immediately discontinue use of the accessories and arrange for return of the products. They were also told that they could continue to use the CD5 Machine without the recalled accessories. A Product Recall Response Form was to completed by each consignee. Questions are directed to the firm at 800-221-7943. |
| Quantity | 2 units |
| Distribution | CA, PA, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092463 | SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM Sorin Group Deutschland GmbH, Nov 5, 2009 |