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Terminated

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

FDA Recall Z-0280-2009 · Posted 2008-11-07

Recalling FirmC. R.Bard, Inc./BardElectrophysiology Division
Recall StatusTerminated
Product CodeDYB
Date Initiated2008-10-01
Date Terminated2010-03-09
Product Quantity3,105 kits

Reason for Recall

Failure to insert the guidewire through the introducer needle.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K934901TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVEThomas Medical Products, Inc. · 1994-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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