Portable Lifecare Ventilator Plv-102

• 9 recalls, same reason

  • Terminated Z-1080-2008 FDA Unclassified (pre-2012) ·initiated 15 Oct 2007
  • Terminated Z-1070-2008 FDA Unclassified (pre-2012) ·initiated 15 Oct 2007
  • Terminated Z-1056-2008 FDA Unclassified (pre-2012) ·initiated 15 Oct 2007 ·on shared 510(k) K842876
  • Terminated Z-1077-2008 FDA Unclassified (pre-2012) ·initiated 15 Oct 2007
  • Terminated Z-1085-2008 FDA Unclassified (pre-2012) ·initiated 15 Oct 2007
  • Terminated Z-1062-2008 FDA Unclassified (pre-2012) ·initiated 15 Oct 2007
  • Terminated Z-1060-2008 FDA Unclassified (pre-2012) ·initiated 15 Oct 2007
  • Terminated Z-1058-2008 FDA Unclassified (pre-2012) ·initiated 15 Oct 2007 ·on shared 510(k) K842876
  • Terminated Z-1082-2008 FDA Unclassified (pre-2012) ·initiated 15 Oct 2007

  Foreign material: Glass fragments may present in the plastic bag material used to ship components.

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

510(k) Number

K842876 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• Lifecare Remote Alarm #34-001

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