| Class 1 Device Recall Millar disposable angiographic catheter (Left Heart) | |
Date Initiated by Firm | March 08, 2011 |
Date Posted | March 24, 2011 |
Recall Status1 |
Terminated 3 on June 27, 2011 |
Recall Number | Z-1725-2011 |
Recall Event ID |
58123 |
510(K)Number | K952773 K993694 |
Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
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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 TX 77023
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For Additional Information Contact | 713-923-9171 |
Manufacturer Reason for Recall | Possibility of epoxy debris particles inside the catheter lumen. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DQO
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