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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 1 Recall
Millar disposable angiographic catheter (Left Heart)		see related information
Date Posted March 24, 2011
Recall Number Z-1725-2011
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.
Code Information 800-4219-1 and 800-4219-3 Listing #: D055900 and D055901
Recalling Firm/
Manufacturer		 Millar Instruments, Inc
6001-A Gulf Fwy
Houston, Texas 77023
Consumer Instructions Contact the recalling firm for information
Reason for
Recall		 Possibility of epoxy debris particles inside the catheter lumen.
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.
 
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