Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular int
FDA device recall Z-1227-2011 · posted 2011-02-14 · Terminated
Recall details
- Recalling firm
- Thomas Medical Products Inc
- Reason for recall
- Compromised sterility/weak or open seals.
- Action taken
- GE Healthcare Thomas medical products Recall notification dated 16 December 2010 (GEHC Ref # 35003) was sent by letter via UPS Next Day Air and/or USPS certified mail.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 28,679 for all products
- Distribution
- Distribution Nationwide USA and Germany.
- Date initiated
- 2010-12-16
- Date posted
- 2011-02-14
- Date terminated
- 2012-08-08
- 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 |