CLASS I Device recall · Reported 10 Aug 2016 · FDA Enforcement Report

Oxylog 3000, Disposable Pediatric Patient Circuit recalled

Draeger Medical is recalling Oxylog 3000, Disposable Pediatric Patient Circuit, distributed nationwide in the US. The recall was initiated on 31 May 2016 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesCatalog Number: 5704964

Quantity recalled42,922 units worldwide (US distribution 1,530)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2215-2016
FDA event ID: 74469
Recalling firm: Draeger Medical, Telford, PA
Classification: Class I
Status: Terminated
Recall initiated: 31 May 2016
FDA classified: 4 Aug 2016
Reported: 10 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: CPAP & Ventilators

Timeline

31 May 2016	Recall initiated by company
4 Aug 2016	Classified by FDA	+65 days
10 Aug 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Isolated episodes of leakage at the check valve were found

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide Distribution including states of: AK, CA, FL, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NY,OH,OK,OR,PA,TN,TX,UT,VA,WA, and WI.

Nationwide Alaska California Florida Iowa Illinois Indiana Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina New Hampshire New York Ohio Oklahoma

Questions about this recall

Why was it recalled?

Isolated episodes of leakage at the check valve were found

Which lots are affected?

Catalog Number: 5704964

Where was it sold?

US Nationwide Distribution including states of: AK, CA, FL, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NY,OH,OK,OR,PA,TN,TX,UT,VA,WA, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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