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U.S. Department of Health and Human Services

Class 1 Device Recall Crossover Reinforced Catheter Introducer System

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  Class 1 Device Recall Crossover Reinforced Catheter Introducer System see related information
Date Initiated by Firm October 21, 2009
Date Posted November 24, 2009
Recall Status1 Terminated 3 on November 08, 2010
Recall Number Z-0120-2010
Recall Event ID 53672
510(K)Number K083269  
Product Classification Introducer, catheter - Product Code DYB
Product Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.
Code Information Cordis lot numbers - U0000025, U0000026, U0000027, U0000028, U0000029, U0000030, U0000031, U0000032, U0000033, U0000034, U0000035, U0000036, U0000037, U0000038, U0000039, U0000040, U0000041, U0000042, U0000043, U0000044, U0000045, U0000046, U0000047, U0000048, U0000049, U0000050, U0000051, U0000052, U0000053, U0000054, U0000055, U0000056, U0000057, U0000058, U0000059, U0000060, U0000061, and U0000062. CSI lot numbers - S28117, S28118, S28119, S28127, S28150, S28151, S28727, S28728, S28777, S28778, S28779, S28787, S28804, S28898, S28945, S28967, S29174, S29175, and S29528. 
Recalling Firm/
Manufacturer		 Thomas Medical Products Inc
65 Great Valley Pkwy
Malvern PA 19355-1302
For Additional Information Contact Customer Services
866-446-3003
Manufacturer Reason
for Recall		 Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.
FDA Determined
Cause 2		 Component design/selection
Action An "Urgent Medical Device Correction" letter dated October 22, 2009 was issued to the direct accounts. The letter described the problem and actions for consignees. Consignees were instructed to cease distribution of the recalled product and to notify their subaccounts of the problem. In addition, customers were instructed to return the affected, unused product to Thomas Medical Product, Inc.'s contract warehouse, Inner-Space Warehouse, Inc. Contact your local sales representative for questions about the recall, or Customer Service by calling 1-866-446-3003, Monday through Friday from 8:30AM to 5:OOPM Eastern Standard Time, for questions about product return.
Quantity in Commerce 17,236 units
Distribution United States (FL and MN).
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 = DYB and Original Applicant = THOMAS MEDICAL PRODUCTS, INC.
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