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U.S. Department of Health and Human Services

Class 2 Device Recall QuickCross Support Catheters

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 Class 2 Recall
QuickCross Support Catheters
see related information
Date Posted February 05, 2008
Recall Status1 Terminated on February 08, 2008
Recall Number Z-0698-2008
Recall Event ID 45949
Product Classification Catheter, Percutaneous - Product Code DQY
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, Colorado 80907-5159
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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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

 
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.
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