Safesheath Msp Introducer Sheath Kit with Integral Hemostasis Valve

• • Terminated Z-0168-2012 FDA Unclassified (pre-2012) ·initiated 7 Oct 2011

  Radiopaque (RO)/soft tip of the braided core component in the CSG kits may detach from the braided core tube.

• 3 recalls, same reason

  • Terminated Z-1225-2011 FDA Unclassified (pre-2012) ·initiated 16 Dec 2010 ·on shared 510(k) K003731
  • Terminated Z-1227-2011 FDA Unclassified (pre-2012) ·initiated 16 Dec 2010
  • Terminated Z-1228-2011 FDA Unclassified (pre-2012) ·initiated 16 Dec 2010 ·on shared 510(k) K003731

  Compromised sterility/weak or open seals.

• • Terminated Z-0661-2010 FDA Unclassified (pre-2012) ·initiated 17 Dec 2009

  Radiopaque sheath tip may fracture

• • 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.

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

510(k) Number

K003731 ↗

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

• Tear-Away Sheath Introducer Set with Integral Hemostasis Valve

  Class II

  FDA 510(k) K934901 Active Cleared 21 Jan 1994

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