7F Bard SSV 13 cm Split Sheath with Valve and sideport Catalog Number: 808700 Distributed By: Bard Electrophysiology. Th
FDA device recall Z-0280-2009 · posted 2008-11-07 · Terminated
Recall details
- Recalling firm
- C. R.Bard, Inc./BardElectrophysiology Division
- Reason for recall
- Failure to insert the guidewire through the introducer needle.
- Action taken
- Bard issued a recall notice on 1 October 2008 [note that the letter is dated 29 September 2008] to all recipients of affected product via certified mail. Users are requested to discontinue use and return inventory. Contact Bard Customer Service at 1-800-824-8724 for assistance.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DYB
- Quantity affected
- 3,105 kits
- Distribution
- Nationwide
- Date initiated
- 2008-10-01
- Date posted
- 2008-11-07
- Date terminated
- 2010-03-09
- Location
- Lowell, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE (K934901) | Thomas Medical Products, Inc. | 1994-01-21 |