SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Se
FDA device recall Z-0168-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Thomas Medical Products Inc
- Reason for recall
- Radiopaque (RO)/soft tip of the braided core component in the CSG kits may detach from the braided core tube.
- Action taken
- The firm,GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 7, 2011, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately segregate all affected product in a manner that ensures it will not be used; return any product with reference to the return authorization (RA) number or contact customer service representative to facilitate return of product; if any affected product has been forwarded to another facility, contact that facility to arrange return, and complete and return the attached product reconciliation form. If you have any questions, you may contact the Customer Service number at 1-866-446-3003 Monday through Friday from 8:30am to 5:00pm EDT.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 33,134
- Distribution
- Nationwide distribution: CA only.
- Date initiated
- 2011-10-07
- Date posted
- 2012-01-11
- Date terminated
- 2012-08-29
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE (K003731) | Thomas Medical Products, Inc. | 2001-04-10 |