Z-1948-2009

BARD Simpulse" SOLO System with Soft Splash Shield Tip

Name: Z-1948-2009 BARD Simpulse" SOLO System with Soft Splash Shield Tip
Creator: Davol, Inc., Sub. C. R. Bard, Inc.
Published: 2009-07-30
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2009-07-30 / Terminated / root cause: manufacturing process

FDA source

Davol, Inc., Sub. C. R. Bard, Inc. began a recall of BARD Simpulse" SOLO System with Soft Splash Shield Tip Product Code: 0067590. The Simpulse SOLO Suction/Irrigator is designed to provide controlled powered... on 2009-07-30. The reason FDA records is "Product sterility may be compromised due to lack of package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1948-2009
Status: Terminated
Initiated: 2009-07-30
Posted: 2009-09-06
Terminated: 2016-08-17
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: 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.
Product code: FHQ Holder, Needle, Gastroenterologic
Reason for recall: Product sterility may be compromised due to lack of package integrity.
Root cause tag: manufacturing process
FDA 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 in commerce: 1,140 units
Distribution: Nationwide.
Product codes and lots: Lot Number JUSHF083.

Product code FHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)