Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.

FDA Recall Z-0018-2011 · Posted 2010-10-07

Recalling FirmDraeger Medical Systems, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2010-08-19
Date Terminated2010-11-18
Product Quantity78 potentially afftected units

Reason for Recall

Patients received insufficient ventilation. The Oxylog 3000 Instructions are inadequate relating to dead space volume.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062267OXYLOG 3000Drager Medical B.V. · 2006-10-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑