MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular Intended to be used as a mechanism for the
FDA device recall Z-0604-2009 · posted 2008-12-30 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- Two lots of Cordis Neurovascular Masstransit Infusion Catheter Kits has the potential for sterile PTFE contamination within the inner lumen of the catheter.
- Action taken
- A Medical Device Recall letter, dated 6/30/2008, and Acknowledgement Form were sent overnight. The firm asked customers to set aside any affected product in a manner that ensures it will not be used. Customers are asked to review, sign and return the enclosed Acknowledgement Form directly to Cordis Neurovascular. Customers can either return any product with reference to the RA# on the form, or contact their local sales reps to facilitate return of the affected product. Customers will receive a credit for the units they return. If any affected product has been forwarded to another facility, the facility should be contacted to arrange return of the product. If there are any additional questions, Customer Service may be also be contacted at 800-551-7683.
- Root cause
- Pending
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 27
- Distribution
- Nationwide Distribution --- including states of Colorado, Connecticut, Florida, Minnesota, Nebraska, Nevada, Ohio, Oregon, and Virginia.
- Date initiated
- 2008-06-30
- Date posted
- 2008-12-30
- Date terminated
- 2009-01-02
- 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 |
|---|---|---|
| 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS (K983003) | Cordis Neurovascular, Inc. | 1998-09-17 |