Z-0562-04

BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18...

Name: Z-0562-04 BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18...
Creator: C.R. Bard, Inc., Urological Division
Published: 2004-02-10
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2004-02-10 / Terminated / root cause: labeling and UDI

FDA source

C.R. Bard, Inc., Urological Division began a recall of BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water... on 2004-02-10. The reason FDA records is "The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0562-04
Status: Terminated
Initiated: 2004-02-10
Posted: 2004-02-27
Terminated: 2004-07-09
Recalling firm: C.R. Bard Inc
Product: BardiaComplete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: 5cc Silicone Elastomer-Coated Foley Catheter, Waterproof underpad, Synthetic Vinyl Gloves (2), Lubricant, 10cc Syringe (prefilled with sterile water to inflate Foley catheter), Povidone-Iodine swabs (3), CSR Wrap, Plastic Tray. CR.Bard, Inc., Covington,GA 30014, 222.;bardmedical.com.
Product code: KOD Catheter, Urological
Reason for recall: The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by certified mail on 02/10/2004.
Quantity in commerce: 1100 units (110 cases)
Distribution: AL, CA, CO, FL, GA, IL, IN, KY, MO, MS, NJ, NY, OH, PA, TX and WA.
Product codes and lots: Catalog Number: 800518, Lot Number: 76IN0317

Product code KOD

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)