Medical Air Compressor Model #8413419
FDA device recall Z-0674-2007 · posted 2007-04-05 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- Compressors not providing sufficient supply pressure to connected medical ventilator
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTI
- Quantity affected
- 67 units
- Distribution
- Nationwide.
- Date initiated
- 2007-01-26
- Date posted
- 2007-04-05
- Date terminated
- 2007-06-15
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDICAL AIR COMPRESSOR, MODEL # 8413419 (K982789) | Drager, Inc. | 1998-10-29 |