Z-0314-04

Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014

Name: Z-0314-04 Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
Creator: C.R. Bard, Inc., Urological Division
Published: 2003-12-22
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2003-12-22 / Terminated / root cause: packaging

FDA source

C.R. Bard, Inc., Urological Division began a recall of Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014 on 2003-12-22. The reason FDA records is "Product packaging may contain holes compromising sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0314-04
Status: Terminated
Initiated: 2003-12-22
Posted: 2004-01-09
Terminated: 2004-09-01
Recalling firm: C.R. Bard Inc
Product: Bard Dimension Stone Basket, Rx only, Sterile, C.R.Bard, Inc., Covington, GA 30014
Product code: FFL Dislodger, Stone, Basket, Ureteral, Metal
Reason for recall: Product packaging may contain holes compromising sterility.
Root cause tag: packaging
FDA root cause: Other
Action: Consignees were notified by certified letter on 12/22/2003.
Quantity in commerce: 12,684 units (total includes both types)
Distribution: Product was distributed Nationwide, Canada, Belgium and Japan
Product codes and lots: Catalog numbers: 042310, 042313, 042316, 043310, 043313, 043316, 045215, 045290, 045315, 045390 and 045490.

Product code FFL

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)