Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18
FDA device recall Z-0018-2011 · posted 2010-10-07 · Terminated
Recall details
- Recalling firm
- Draeger Medical Systems, Inc.
- Reason for recall
- Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 78 potentially afftected units
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-08-19
- Date posted
- 2010-10-07
- Date terminated
- 2010-11-18
- Location
- Telford, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXYLOG 3000 (K062267) | Drager Medical B.V. | 2006-10-31 |