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Recall Observatory FDA recall evidence

Device 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.

Z-2215-2016

May 31, 2016

Class I

Product summary

Firm
Draeger Medical, Inc.
Event
Event 74469
Status
Terminated
Classification
Class I
Quantity
42,922 units worldwide (US distribution 1,530)
Official record key
device-enforcement:Z-2215-2016

Official wording

Reason: Isolated episodes of leakage at the check valve were found

Code information: Catalog Number: 5704964

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Isolated episodes of leakage at the check valve were found