Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side
FDA device recall Z-0661-2010 · posted 2010-02-02 · Terminated
Recall details
- Recalling firm
- Thomas Medical Products Inc
- Reason for recall
- Radiopaque sheath tip may fracture
- Action taken
- GE Healthcare Thomas Medical Products firm issued an Urgent Medical Device Correction email on 12/23/09 to the distributor to discontinue distribution and return any affected products. The distributor was instructed to conduct a sub recall regarding the issue. Press issued 1/29/2010.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 60,982 units
- Distribution
- Nationwide.
- Date initiated
- 2009-12-17
- Date posted
- 2010-02-02
- Date terminated
- 2010-11-01
- 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 |