Recall Z-1985-2013 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Sorin Group USA, Inc.
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
| Date | Aug 20, 2013 (initiated Jul 8, 2013) |
| Status | Terminated |
| Reason | Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch. |
| Root cause | Material/Component Contamination |
| Action | On 7/8/13, customers and distributors were sent a "Field Safety Notice Product Recall" letter and requested to return unused Edwards Suction Wands found in the Perfusion Packs to the Sorin Group. Customers are to contact Sorin Group Customer Service at 1-800-650-6502 to receive instructions for returning the affected Edwards Suction Wand to Sorin. Customers were also advised to not discard affected product. |
| Quantity | 18,927 packs |
| Distribution | Nationwide Distribution |
| 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 |