Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA
FDA device recall Z-0087-2010 · posted 2009-11-05 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- Cordis has received complaints of stretching or fracture of the sheath shaft during use.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 2,362 units
- Distribution
- Worldwide Distribution -- United States, Belgium, Switzerland, Germany, Finland, France, Italy, Netherlands, Sweden and United Kingdom.
- Date initiated
- 2009-10-15
- Date posted
- 2009-11-05
- Date terminated
- 2013-08-12
- Location
- Miami Lakes, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CROSSOVER (K083269) | Thomas Medical Products, Inc. | 2009-02-03 |