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U.S. Department of Health and Human Services

Class 2 Device Recall GuideLiner V2 Catheter

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 Class 2 Recall
GuideLiner V2 Catheter
see related information
Date Posted May 24, 2012
Recall Status1 Terminated on July 19, 2012
Recall Number Z-1655-2012
Recall Event ID 61825
Premarket Notification
510(K) Number
K112082 
Product Classification Catheter, Percutaneous - Product Code DQY
Product Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Intended to be used in conjunction with guide catheters to access discrete regions of the coronary and or peripheral vasculature and too facilitate placement and exchange of guidewired and other interventional devices.
Code Information 555038
Recalling Firm/
Manufacturer
Vascular Solutions, Inc.
6464 Sycamore Ct N
Minneapolis, Minnesota 55369-6032
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating from the pushwire on the device. This may cause a procedural delay and/or injury possibly requiring medical intervention.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action Vascular Solutions sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 17, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product , immediately remove the product and place the product in a secure area. Additionally, customers were asked to complete and return a Field Action Customer Inventory Form to the Customer Service Department via fax at 763-656-4251 or e-mail at customerservice@vasc.com. Customers may contact their local sales representative for questions concerning this recall.
Quantity in Commerce 330
Distribution Nationwide Distribution including the states of AL, AZ, AR, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LAM ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, WA, WV, and WI.
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 = DQY and Original Applicant = VASCULAR SOLUTIONS, INC.
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