Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator
This recall has been terminated (originally issued February 14, 2006).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- December 28, 2005
- Posted
- February 14, 2006
- Terminated
- August 7, 2007
- Recall Number
- Z-0515-06
- Quantity
- 2261 units
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Failure to generate an alarm when an unintended disconnection occurrs
Distribution
Product was shipped to medical facilities nationwide
Lot / Code Info
Catalog numbers 8418300, 8411162, 8418002, and 8418000
Root Cause
Other
Action Taken
Recalling firm has issued a medical device recall letter to consignees to the attention of the Director, Neonatal Intensive Care Unit via Certified Mail to alert them of additional monitoring requirements if a PEEP setting of less than 2.5 mbar is used
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