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U.S. Department of Health and Human Services

Class 2 Device Recall GALT MEDICAL GUIDEWIRE

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  Class 2 Device Recall GALT MEDICAL GUIDEWIRE see related information
Date Initiated by Firm April 11, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on October 28, 2008
Recall Number Z-1909-2008
Recall Event ID 47856
510(K)Number K031916  
Product Classification Catheter Guide Wire - Product Code DQX
Product CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.
Code Information Lot number MAPA870
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438-2936
For Additional Information Contact Susan Smith, RN BSN
215-256-4201
Manufacturer Reason
for Recall		 kit contains incorrect component
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product.
Quantity in Commerce 100 units
Distribution The products were shipped to customers in PA and TX.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = GALT MEDICAL CORP.
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