Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane Oxygenator

• 2 recalls, same reason

  • Terminated Z-1424-06 FDA Unclassified (pre-2012) ·initiated 26 Jun 2006
  • Terminated Z-1427-06 FDA Unclassified (pre-2012) ·initiated 26 Jun 2006

  Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the surface area needed for proper heat transfer.

510(k) Number

K013480 ↗

FDA Product Code

DTZ

Device Class

Class II

Regulation

21 CFR Part 870.4350

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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