Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0674-2007

Medical Air Compressor Model #8413419

Draeger, Inc. / initiated 2007-01-26 / Terminated

Draeger Medical, Inc. began a recall of Medical Air Compressor Model #8413419 on . The reason FDA records is "Compressors not providing sufficient supply pressure to connected medical ventilator". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0674-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Draeger, Inc.
Product
Medical Air Compressor Model #8413419
Product code
BTI Compressor, Air, Portable
Reason for recall
Compressors not providing sufficient supply pressure to connected medical ventilator
FDA root cause
Other
Action
The 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.
Quantity in commerce
67 units
Distribution
Nationwide.
Product codes and lots
Model number 8413419. Catalog number 8413419. Serial Numbers ARXC-001; ARXC-0002; ARXC-0009; ARXC-0011; ARXC-0012; ARXC-0013; ARXC-0014; ARXC-0015; ARXC-0016; ARXC-0017; ARXC-0019; ARXC-0020; ARXD-0034; ARXD-0035; ARXD-0036; ARXD-0037; ARXD-0038; ARXD-0039; ARXD-0040; ARXE-0081; ARXE-0082; ARXE-0083; ARXE-0084; ARXE-0085; ARXE-0086; ARXE-0087; ARXE-0088; ARXE-0089; ARXE-0090; ARXE-0091; ARXE-0092; ARXE-0093; ARXE-0094; ARXE-0095; ARXE-0096; ARXE-0097; ARXE-0098; ARXE-0099; ARXE0100; ARXE-0101; ARXE-0102; ARXE-0103; ARXE-0104; ARXE-0106; ARXE-0107; ARXE-0108; ARXE-0109; ARXE-0110; ARXE-0111; ARXE-0112; ARXE-0113; ARXE-0114; ARXE-0115; ARXE-0116; ARXE-0117; ARXE-0118; ARXE-0119; ARXE-0120; ARXE-0121; ARXE-0122; ARXE-0123; ARXE-0124; ARXE-0125; ARXE-0126; ARXE-0127; ARXE-0128; and ARXE-0129.