Z-0002-04

Opti-Plast Balloon Dilatation Catheters

Name: Z-0002-04 Opti-Plast Balloon Dilatation Catheters
Creator: Bard Peripheral Vascular Inc
Published: 2003-08-20
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2003-08-20 / Terminated

FDA source

Bard Peripheral Vascular Inc began a recall of Opti-Plast Balloon Dilatation Catheters on 2003-08-20. The reason FDA records is "Product intended for distribution outside USA was distributed without premarket notification requirements being met". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0002-04
Status: Terminated
Initiated: 2003-08-20
Posted: 2003-10-15
Terminated: 2005-11-21
Recalling firm: Bard Peripheral Vascular Inc
Product: Opti-Plast Balloon Dilatation Catheters
Product code: GBR
Reason for recall: Product intended for distribution outside USA was distributed without premarket notification requirements being met.
FDA root cause: Other
Action: The firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return.
Quantity in commerce: 14 units
Distribution: OH, AL, MS, LA, VA
Product codes and lots: Models: XT75410, XT100410, XT120410

Product code GBR

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)