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Recall Observatory FDA recall evidence

Device product

VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.

Z-0740-2019

December 21, 2018

Class I

Product summary

Firm
Draeger Medical, Inc.
Event
Event 81874
Status
Terminated
Classification
Class I
Quantity
25 units
Official record key
device-enforcement:Z-0740-2019

Official wording

Reason: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit

Code information: All Lots

Distribution pattern: US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit