The Recall Desk
SevereFDA (Devices)·Z-2215-2016·Announced 2016-08-10

Draeger Recalls Oxylog 3000 Pediatric Patient Circuits Due to Leakage

Draeger Medical is recalling Oxylog 3000 disposable pediatric patient circuits because isolated episodes of leakage were found at the check valve.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.

Plain-English summary

Draeger Medical, Inc. is recalling the Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number 5704964. The recall involves 42,922 units worldwide, with 1,530 units distributed in the United States. The product is used with the Dräger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.

The recall was initiated due to isolated episodes of leakage at the check valve. The affected units were distributed nationwide in the US, including in Alaska, California, Florida, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.

Consumers and healthcare facilities should stop using the affected patient circuits and contact Draeger Medical, Inc. for further instructions or a replacement.

The recalled product

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.
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Catalog Number: 5704964

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically: