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Terminated

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.

FDA Recall Z-1948-2009 · Posted 2009-09-06

Recalling FirmDavol, Inc., Sub. C. R. Bard, Inc.
Recall StatusTerminated
Product CodeFHQ
Date Initiated2009-07-30
Date Terminated2016-08-17
Product Quantity1,140 units

Reason for Recall

Product sterility may be compromised due to lack of package integrity.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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