FDA Medical Device Recalls (openFDA)
Draeger Medical Systems, Inc.: Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
- Recall number
- Z-0018-2011
- Recalling firm
- Draeger Medical Systems, Inc.
- Product
- Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
- Status
- Terminated
- Initiated
- 2010-08-19
- Posted
- 2010-10-07
- Terminated
- 2010-11-18
- 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 Technical Support at 1-800-543-5047 or your local Drager Sales Representative.
- Quantity
- 78 potentially afftected units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- only units manufactured before 9/08
- 510(k) numbers
- ["K062267"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2510954
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28