Pasco Mic and Mic/Id Panels

• 8 recalls, same reason

  • Terminated Z-1466-2008 FDA Unclassified (pre-2012) ·initiated 22 Feb 2008 ·on shared 510(k) K010508
  • Terminated Z-1470-2008 FDA Unclassified (pre-2012) ·initiated 22 Feb 2008 ·on shared 510(k) K010508
  • Terminated Z-1465-2008 FDA Unclassified (pre-2012) ·initiated 22 Feb 2008 ·on shared 510(k) K010508
  • Terminated Z-1467-2008 FDA Unclassified (pre-2012) ·initiated 22 Feb 2008 ·on shared 510(k) K010508
  • Terminated Z-1463-2008 FDA Unclassified (pre-2012) ·initiated 22 Feb 2008 ·on shared 510(k) K010508
  • Terminated Z-1464-2008 FDA Unclassified (pre-2012) ·initiated 22 Feb 2008 ·on shared 510(k) K010508
  • Terminated Z-1469-2008 FDA Unclassified (pre-2012) ·initiated 22 Feb 2008 ·on shared 510(k) K010508
  • Terminated Z-1468-2008 FDA Unclassified (pre-2012) ·initiated 22 Feb 2008 ·on shared 510(k) K010508

  The failure of an electronic component could result in failure of the ventilator to breathe for the patient and/or failure of the ventilator to properly alarm to alert the caregiver.

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

510(k) Number

K010508 ↗

FDA Product Code

LTT

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Pasco Mic and Mic/Id Panels, Quinupristin/Dalfopristin

  Class II

  FDA 510(k) K992717 Active Cleared 2 Nov 1999

• Pasco Mic and Mic/Id Panels

  Class II

  FDA 510(k) K944517 Active Cleared 19 Oct 1994

• Pasco Mic and Mic/Id Panels/ Cefdinir

  Class II

  FDA 510(k) K982156 Active Cleared 29 Jul 1998

• Pasco Mic and Mic/Id Panels, Vancomycin

  Class II

  FDA 510(k) K992296 Active Cleared 21 Sep 1999

• Pasco Mic Panels/ Gent & Strep Synergy

  Class II

  FDA 510(k) K934380 Active Cleared 27 Jan 1994

• Pasco Mic and Mic/Id Panels (Ofloxacin)

  Class II

  FDA 510(k) K992077 Active Cleared 3 Sep 1999

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