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, tissue debris and foreign matter from the operative or wound site. When connected to a suction source, the device can be used to aspirate fluids from the operative or wound site.
This recall has been terminated (originally issued September 6, 2009).
- Recall Initiated
- July 30, 2009
- Posted
- September 6, 2009
- Terminated
- August 17, 2016
- Recall Number
- Z-1948-2009
- Quantity
- 1,140 units
- Firm Location
- Warwick, RI
- Official Source
- View on FDA website ↗
Reason for Recall
Product sterility may be compromised due to lack of package integrity.
Distribution
Nationwide.
Lot / Code Info
Lot Number JUSHF083.
Root Cause
Process control
Action Taken
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.
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