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Class 2 Device Recall QuickCross Support Catheters |
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Date Initiated by Firm |
December 10, 2007 |
Date Posted |
February 05, 2008 |
Recall Status1 |
Terminated 3 on February 08, 2008 |
Recall Number |
Z-0698-2008 |
Recall Event ID |
45949 |
Product Classification |
Catheter - Product Code DQY
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Product |
Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectranetics, Colorado Springs, Colorado 80907. |
Code Information |
Lot Number: 0709158 |
Recalling Firm/ Manufacturer |
Spectranetics Corporation 96 Talamine Ct Colorado Springs CO 80907-5159
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For Additional Information Contact |
719-447-2289
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Manufacturer Reason for Recall |
Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.
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FDA Determined Cause 2 |
Packaging process control |
Action |
Consignees were notified by Dear Healthcare provider letter on 12/10/2007 and were told that a sales rep would remove and replace all affected catheters. |
Quantity in Commerce |
64 |
Distribution |
Nationwide including states of FL, IL, IN, MO, NC, NY, TX, and UT. |
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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