Recall Z-0087-2010 ยท DYB Introducer, Catheter
Cordis Corporation
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 an
| Date | Nov 5, 2009 (initiated Oct 15, 2009) |
| Status | Terminated |
| Reason | Cordis has received complaints of stretching or fracture of the sheath shaft during use. |
| Root cause | 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 |
| Quantity | 2,362 units |
| Distribution | Worldwide Distribution -- United States, Belgium, Switzerland, Germany, Finland, France, Italy, Netherlands, Sweden and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083269 | CROSSOVER Thomas Medical Products, Inc., Feb 3, 2009 |