—#85892

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.

FDA product code: DYB — Introducer, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K083269
Affected lot / code info: 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.

Why it was recalled

Cordis has received complaints of stretching or fracture of the sheath shaft during use.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm: Cordis Corporation
Address: 14201 Nw 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern: Worldwide Distribution -- United States, Belgium, Switzerland, Germany, Finland, France, Italy, Netherlands, Sweden and United Kingdom.

Timeline

Recall initiated: 2009-10-15
Posted by FDA: 2009-11-05
Terminated: 2013-08-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85892. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.