Recall Z-0018-2011 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical Systems, Inc.
Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
| Date | Oct 7, 2010 (initiated Aug 19, 2010) |
| Status | Terminated |
| Reason | Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume. |
| Root cause | Error in labeling |
| Action | 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 T |
| Quantity | 78 potentially afftected units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062267 | OXYLOG 3000 Drager Medical B.V., Oct 31, 2006 |