Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX, Torflex, Braided Guiding Introducer Kit).
FDA device recall Z-0815-2010 · posted 2010-03-04 · Terminated
Recall details
- Recalling firm
- Thomas Medical Products Inc
- Reason for recall
- Radiopaque tip may fracture
- Action taken
- Thomas Medical Products, A GE Healthcare Company, issued an "Urgent Medical Device Correction" letter dated February 1, 2010. Consignees were informed of the affected product then asked to cease distribution, return any product to firm and contact all sub-accounts. For further information, contact Thomas Medical Products Customer Service at 1-866-446-3003.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 13,973 units
- Distribution
- Worldwide Distribution -- United States (CA, MA and NJ), Canada, Germany, and the United Kingdom.
- Date initiated
- 2010-02-01
- Date posted
- 2010-03-04
- Date terminated
- 2011-01-05
- 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 |
|---|---|---|
| MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM (K040713) | Thomas Medical Products, Inc. | 2004-06-01 |