Medcomp Repair Kit, Model Aspcrpk

• 9 recalls, same reason

  • Terminated Z-1127-2018 FDA Class II ·initiated 23 Feb 2018
  • Terminated Z-1123-2018 FDA Class II ·initiated 23 Feb 2018
  • Terminated Z-1124-2018 FDA Class II ·initiated 23 Feb 2018
  • Terminated Z-1126-2018 FDA Class II ·initiated 23 Feb 2018
  • Terminated Z-1119-2018 FDA Class II ·initiated 23 Feb 2018
  • Terminated Z-1118-2018 FDA Class II ·initiated 23 Feb 2018
  • Terminated Z-1122-2018 FDA Class II ·initiated 23 Feb 2018
  • Terminated Z-1125-2018 FDA Class II ·initiated 23 Feb 2018
  • Terminated Z-1120-2018 FDA Class II ·initiated 23 Feb 2018

  There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.

510(k) Number

K022570 ↗

FDA Product Code

NFK

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K081904 Active Cleared 23 Sep 2008

• Medcomp Ash Split-Cath 28cm, Medcomp Ash Split-Cath 32cm

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  FDA 510(k) K972207 Active Cleared 23 Feb 1998

• Split Cath Rg

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  FDA 510(k) K130889 Active Cleared 28 Apr 2014

• Medcomp Split-Cath II

  Class II

  FDA 510(k) K040318 Active Cleared 3 Feb 2005

• Medcomp Split Cath II

  Class II

  FDA 510(k) K051280 Active Cleared 30 Nov 2005

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