Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
- Company
- Draeger Medical Systems, Inc.
- Recall Initiated
- August 19, 2010
- Posted
- October 7, 2010
- Terminated
- November 18, 2010
- Recall Number
- Z-0018-2011
- Quantity
- 78 potentially afftected units
- Firm Location
- Telford, PA
Reason for Recall
Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume.
Distribution
Nationwide Distribution
Lot / Code Info
only units manufactured before 9/08
Root Cause
Error in labeling
Action Taken
The firm sent Important Safety Notice Letter, dated August 2010, and Instructions for Use supplement to consignees. The letter explained the issue with the affected product. The letter asks customers to attach the Instructions for Use amendment sheet supplied with the letter to their corresponding Instructions for Use. The firm also states that a they will provide a dedicated pediatric breathing circuit for the Oxylog 3000. Questions regarding the letter should be directed to Michael Kelhart at 1-800-543-5047. Questions regarding the use of the device should be directed to DragerService Technical Support at 1-800-543-5047 or your local Drager Sales Representative.