ClearanceBrief
Recall Z-0674-2007 ยท BTI Compressor, Air, Portable

Draeger Medical, Inc.

Medical Air Compressor Model #8413419

DateApr 5, 2007 (initiated Jan 26, 2007)
StatusTerminated
ReasonCompressors not providing sufficient supply pressure to connected medical ventilator
Root causeOther
ActionThe recalling firm issued a Medical Device Recall Letter dated 1/22/07 to their customers via Certified Mail. An authorized service representative will inspect each potentially affected device. If a device is found to have an affected dryer assembly, it will be repaired free of charge.
Quantity67 units
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K982789MEDICAL AIR COMPRESSOR, MODEL # 8413419
Drager, Inc., Oct 29, 1998