Conmed: Stat 2 and Stat 2 Pumpette Extension Sets and Masterflow and Masterflow Pumpette Primary Sets

• • Terminated Z-0805-2018 FDA Class II ·initiated 19 Jun 2017

  Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.

• 5 recalls, same reason

  • Terminated Z-0684-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011
  • Terminated Z-0685-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011
  • Terminated Z-0688-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011
  • Terminated Z-0687-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011
  • Terminated Z-0686-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011

  ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette Compensating Controller on several complaint samples had been assembled incorrectly.

• 6 recalls, same reason

  • Terminated Z-0636-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011
  • Terminated Z-0632-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011
  • Terminated Z-0631-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011
  • Terminated Z-0633-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011
  • Terminated Z-0630-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011
  • Terminated Z-0635-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011

  ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate and might reduce the ability of the user to regulate the device at low flow rates.

510(k) Number

K964844 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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