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.
FDA Recall Z-1725-2011 · Posted 2011-03-24
Recalling FirmMillar Instruments, Inc
Recall StatusTerminated
Product CodeDQO
Date Initiated2011-03-08
Date Terminated2011-06-27
Product Quantity1080 units
Reason for Recall
Possibility of epoxy debris particles inside the catheter lumen.
Firm 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.
Root Cause
Process design
Distribution Pattern
MN, NY, Washington DC, NC, MA, MN, PA, CA, MI, Australia, Germany, Canada, Japan, United Kingdom, and Norway.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.