Z-1539-2009

Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc...

Name: Z-1539-2009 Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc...
Creator: C.R. Bard, Inc., Urological Division
Published: 2009-04-02
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2009-04-02 / Terminated / root cause: manufacturing process

FDA source

C.R. Bard, Inc., Urological Division began a recall of Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA on 2009-04-02. The reason FDA records is "The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing". 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-1539-2009
Status: Terminated
Initiated: 2009-04-02
Posted: 2009-06-29
Terminated: 2009-12-04
Recalling firm: C.R. Bard Inc
Product: Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA.
Product code: FPA Set, Administration, Intravascular
Reason for recall: The affected units may contain extension sets with the microbore tubing instead of extension sets with the macrobore tubing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All consignees were notified by an Urgent: Product Recall Notification letter via Fed-Ex carrier on 04/02/2009. They were instructed not to use or further distribute any of the affected products. They were advised to check their inventory and to remove and return affected product to Bard Medical Division. A Recall & Effectiveness Check Form was included to be filled out and returned via fax, to Bard.
Quantity in commerce: 16,100 units
Distribution: Nationwide Distribution - including states of AZ, CA, CO, GA, IA, MN, NE, and TX.
Product codes and lots: Lot #JUSJF441.

Product code FPA

K980992Class IIIV Administration Sets with Needleless Access DevicesVenetec Intl., Inc. / cleared 1998-05-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)