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U.S. Department of Health and Human Services

Class 1 Device Recall Millar disposable angiographic catheter (Left Heart)

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 Class 1 Recall
Millar disposable angiographic catheter (Left Heart)
see related information
Date Posted March 24, 2011
Recall Status1 Terminated on June 27, 2011
Recall Number Z-1725-2011
Recall Event ID 58123
Premarket Notification
510(K) Numbers
K952773  K993694 
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
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
Manufacturer Reason
for Recall
Possibility of epoxy debris particles inside the catheter lumen.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = MILLAR INSTRUMENTS, INC.
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