Recall Z-2215-2016— Draeger Medical, Inc.

Name: FDA recall Z-2215-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-31

Class I · Terminated

Class I FDA medical device recall by Draeger Medical, Inc., initiated 2016-05-31, terminated 2018-03-14. It names one FDA 510(k) clearance: K062267. Product: Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.. Reason: Isolated episodes of leakage at the check valve were found.

Recalling firm: Draeger Medical, Inc.
Classification: Class I
Status: Terminated
Initiated: 2016-05-31
Terminated: 2018-03-14
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K062267 — OXYLOG 3000Drager Medical B.V.·cleared 2006-10-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.

Reason for recall

Isolated episodes of leakage at the check valve were found

Data sourced from openFDA. This site is unofficial and independent of the FDA.