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U.S. Department of Health and Human Services

Class 1 Device Recall CROSSOVER Sheath Introducer

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 Class 1 Recall
CROSSOVER Sheath Introducer
see related information
Date Posted November 05, 2009
Recall Status1 Terminated on August 12, 2013
Recall Number Z-0087-2010
Recall Event ID 53574
Premarket Notification
510(K) Number
K083269 
Product Classification Introducer, Catheter - Product Code DYB
Product Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA. Distributed by Cordis Corporation, 14201 North West 60th Avenue, Miami Lakes, Florida 33014 USA Vital Signs, Ltd. 13-14 Eldon Way Lineside Industrial Estate, Littlehampton, West Sussex, UK. The Cordis CROSSOVER Sheath Introducer is intended for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids.
Code Information Catalog Number: 403545S, Lot Numbers: U0000027, U0000041 and U0000047; Catalog Number: 403585S, Lot Number U0000025; Catalog Number: 403645S, Lot Numbers U0000026, U0000030, U0000031, U0000038 and U0000052; Catalog Number: 403685S, Lot Numbers U0000033, U0000042 and U0000050; Catalog Number: 403745S, Lot Numbers U0000034, U0000035, U0000040, U0000043 and U0000055; and Catalog Number: 403785S, Lot Numbers U0000037 and U0000046.
Recalling Firm/
Manufacturer
Cordis Corporation
14201 Nw 60th Ave
Miami Lakes, Florida 33014-2802
For Additional Information Contact Hal Beden
786-313-2365
Manufacturer Reason
for Recall
Cordis has received complaints of stretching or fracture of the sheath shaft during use.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action A Medical Device Recall letter dated October 19, 2009 was issued to consignees by sending an overnight letter to each account. The letter described the affected device, issue and actions for customers. A Cordis Corporation representative will follow-up and contact consignees as necessary to facilitate obtaining signature, faxing the acknowledgement form to the Cordis Corporation, collecting and returning units. A press release from the Cordis Corporation announced a nationwide recall of the CROSSOVER Sheath Introducer available on (http://www.webwire.com/ViewPressRel.asp?aId=106460). In addition to the local sales representative, customers may contact the special Customer Service number at 1-866-854-1672, Monday through Friday from 8:30 a.m. to 8:00 p.m. Eastern Standard Time, if you have any additional questions relative to product return or alternate product.
Quantity in Commerce 2,362 units
Distribution Worldwide Distribution -- United States, Belgium, Switzerland, Germany, Finland, France, Italy, Netherlands, Sweden and United Kingdom.
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 = DYB and Original Applicant = THOMAS MEDICAL PRODUCTS, INC.
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