Z-1725-2011

Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and...

Name: Z-1725-2011 Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and...
Creator: Millar Instruments, Inc
Published: 2011-03-08
License: https://open.fda.gov/license/

Millar LLC. / initiated 2011-03-08 / Terminated / root cause: manufacturing process

FDA source

Millar Instruments, Inc began a recall of Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F. Provide... on 2011-03-08. The reason FDA records is "Possibility of epoxy debris particles inside the catheter lumen". 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-1725-2011
Status: Terminated
Initiated: 2011-03-08
Posted: 2011-03-24
Terminated: 2011-06-27
Recalling firm: Millar LLC.
Product: Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F. Provide intravascular pressure readings and capability for the deliverance of high-speed injection of radiopaque contrast media used in vascular imaging to selected sites in the vascular system.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Possibility of epoxy debris particles inside the catheter lumen.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm, Millar, notified their consignees/customers by email and sent hardcopy of email on March 8, 2011. The notification described the product, problem and actions to be taken. The customers were instructed to return the catheter(s) to Millar or report back to Millar if the catheter(s) has been consumed. If you have any questions, please do not hesitate to contact Director, RA/QA at 832-667-7000.
Quantity in commerce: 1080 units
Distribution: MN, NY, Washington DC, NC, MA, MN, PA, CA, MI, Australia, Germany, Canada, Japan, United Kingdom, and Norway.
Product codes and lots: 800-4219-1 and 800-4219-3 Listing #: D055900 and D055901

Product code DQO

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)