Stat 2 IV Pumpette

• • Terminated Z-0804-2018 FDA Class II ·initiated 19 Jun 2017

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

• 2 recalls, same reason

  • Terminated Z-0682-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011
  • Terminated Z-0683-2012 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.

• 2 recalls, same reason

  • Terminated Z-0629-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011
  • Terminated Z-0634-2012 FDA Unclassified (pre-2012) ·initiated 15 Apr 2011 ·on shared 510(k) K905498

  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.

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

510(k) Number

K905498 ↗

FDA Product Code

LDR

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• I.V. Stat Master

  Class II

  FDA 510(k) K852254 Active Cleared 18 Nov 1985

• Master Medical Device Is I.V. Stat 2

  Class II

  FDA 510(k) K871753 Active Cleared 5 Jun 1987

• Master I.V. Dial Lock

  Class II

  FDA 510(k) K792560 Active Cleared 20 Dec 1979

• I.V. Instant Timer

  Class II

  FDA 510(k) K913076 Active Cleared 17 Oct 1991

• Master Flow I.V. Pumpette

  Class II

  FDA 510(k) K905497 Active Cleared 16 Apr 1991