18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion Side Port ki
FDA device recall Z-0131-2009 · posted 2008-11-03 · Terminated
Recall details
- Recalling firm
- Thomas Medical Products Inc
- Reason for recall
- Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula.
- Action taken
- On 9/11/08, Thomas Medical Products issued letters to the distributors informing them of the problem, to cease distribution and await further instructions. Additional instructions to the distributors were to notify all their account via an advisory notice and request that the user not use the needle supplied with the kit and to replace with another commercially available sterile 18 gage introducer needle.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 246,585 needles
- Distribution
- Nationwide distribution via distributors in CA, MA, and MN.
- Date initiated
- 2008-09-12
- Date posted
- 2008-11-03
- Date terminated
- 2009-05-06
- 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 |
| TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE (K934901) | Thomas Medical Products, Inc. | 1994-01-21 |