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U.S. Department of Health and Human Services

Class 2 Device Recall SIMPULSE SOLO SUCTION IRRIGATOR

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 Class 2 Device Recall SIMPULSE SOLO SUCTION IRRIGATORsee related information
Date Initiated by FirmJuly 30, 2009
Date PostedSeptember 06, 2009
Recall Status1 Terminated 3 on August 17, 2016
Recall NumberZ-1948-2009
Recall Event ID 52768
Product Classification Holder, needle, gastroenterologic - Product Code FHQ
ProductBARD 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.
Code Information Lot Number JUSHF083.
Recalling Firm/
Manufacturer		 Davol, Inc., Sub. C. R. Bard, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information ContactJohn Uhoch
401-463-7000
Manufacturer Reason
for Recall		Product sterility may be compromised due to lack of package integrity.
FDA Determined
Cause 2		Process control
ActionDavol 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 in Commerce1,140 units
DistributionNationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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