Recall Z-1948-2009 ยท FHQ Holder, Needle, Gastroenterologic
Davol, Inc., Sub. C. R. Bard, Inc.
BARD Simpulse" SOLO System with Soft Splash Shield Tip Product Code: 0067590. The Simpulse SOLO Suction/Irrigator is designed to provide controlled powered irrigation during open orthopedic and general surgical procedures and for the cleansing of burns or wounds. Appropriate fluids for use include fluids with specific gravity less than 1. The pulsatile action of the pump helps to remove blood, t
| Date | Sep 6, 2009 (initiated Jul 30, 2009) |
| Status | Terminated |
| Reason | Product sterility may be compromised due to lack of package integrity. |
| Root cause | Process control |
| Action | Davol issued a Recall Letter dated July 30, 2009 requesting user facilities examine inventory and immediately discontinue use of any product from the affected lot and return it to Davol. Direct questions about the recall to Davol, Inc., Sub. C. R. Bard, Inc. by calling 1-401-463-7000. |
| Quantity | 1,140 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.