DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS - De 31

• 48 recalls, same reason

  • Terminated Z-0331-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0335-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0304-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0292-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0324-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0314-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0329-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0334-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0307-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0298-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0300-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0333-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0289-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0327-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0312-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0297-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0301-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0322-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0323-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0293-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0321-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0317-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0310-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0302-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0325-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0295-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0291-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0303-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0315-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0313-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0318-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0290-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0294-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0326-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0305-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0288-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0332-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0320-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0299-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0296-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0328-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0319-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0316-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0330-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0309-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0308-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0306-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009
  • Terminated Z-0311-2010 FDA Unclassified (pre-2012) ·initiated 23 Oct 2009

  There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential clinical complication is air embolism, particularly for the segment of the patient population that develops negative central venous pressure during normal respira

510(k) Number

K032061 ↗

FDA Product Code

MSD

Models / Variants

DE19

24SH

DE23

28SH

DE27

32SH

De 31

36SH

DE19

24NH

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESK Substantially Equivalent — Kit

• Retro Repair Kit, Model PRRK5

  Class II

  FDA 510(k) K022644 Active Cleared 6 Nov 2002

• Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,

  Class II

  FDA 510(k) K073093 Active Cleared 22 Jan 2008

• 15.5Fr Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55

  Class II

  FDA 510(k) K063441 Active Cleared 12 Feb 2007

• 55cm Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model #RS50SH55, RS50NH55, RE50SH55 & RE50NH55

  Class II

  FDA 510(k) K041559 Active Cleared 30 Jul 2004

• Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and Xrikrt

  Class II

  FDA 510(k) K022620 Active Cleared 11 Oct 2002

• Alta Lr Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40

  Class II

  FDA 510(k) K040509 Active Cleared 19 Apr 2004

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