Tear-Away Sheath Introducer Set with Integral Hemostasis Valve

• 3 recalls, same reason

  • Terminated Z-1225-2011 FDA Unclassified (pre-2012) ·initiated 16 Dec 2010 ·on shared 510(k) K934901
  • Terminated Z-1228-2011 FDA Unclassified (pre-2012) ·initiated 16 Dec 2010 ·on shared 510(k) K934901
  • Terminated Z-1226-2011 FDA Unclassified (pre-2012) ·initiated 16 Dec 2010

  Compromised sterility/weak or open seals.

• • Terminated Z-0280-2009 FDA Unclassified (pre-2012) ·initiated 1 Oct 2008

  Failure to insert the guidewire through the introducer needle.

• • Terminated Z-0131-2009 FDA Unclassified (pre-2012) ·initiated 12 Sep 2008

  Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula.

• • Terminated Z-0297-06 FDA Unclassified (pre-2012) ·initiated 7 Nov 2005

  mislabeled as 9.5F actually contains 10.5F

• • Terminated Z-0056-05 FDA Unclassified (pre-2012) ·initiated 14 Oct 2004

  Sheaths may fracture if exposed to excess fluorescent light

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K934901 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Multi-Port Y Introducer Set

  Class II

  FDA 510(k) K931587 Active Cleared 6 Oct 1993

• Reinforced Catheter Introducer System (Rcis)

  Class II

  FDA 510(k) K081341 Active Cleared 14 May 2008

• Coronary Sinus Guide and Lateral Vein Introducer Kits Open recall

  Class II

  FDA 510(k) K120158 Active Cleared 14 Aug 2012

• Long Length Percutaneous Introducer Set

  Class II

  FDA 510(k) K924456 Active Cleared 22 Mar 1993

• Hemodialysis Introducer Set

  Class II

  FDA 510(k) K961780 Active Cleared 24 Dec 1996

• Transseptal Needle/Trocar

  Class II

  FDA 510(k) K011727 Active Cleared 2 May 2002

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