Recall Z-0280-2009 ยท DYB Introducer, Catheter
C. R.Bard, Inc./BardElectrophysiology Division
7F Bard SSV 13 cm Split Sheath with Valve and sideport Catalog Number: 808700 Distributed By: Bard Electrophysiology. The product is Intended for introduction of various type of pacing leads and catheters
| Date | Nov 7, 2008 (initiated Oct 1, 2008) |
| Status | Terminated |
| Reason | Failure to insert the guidewire through the introducer needle. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 3,105 kits |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934901 | TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE Thomas Medical Products, Inc., Jan 21, 1994 |