PlainRecalls
FDA Devices Critical Class I Terminated

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

Reported: January 30, 2019 Initiated: December 21, 2018 #Z-0740-2019

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Draeger Medical, Inc.
Units Affected
25 units
Distribution
US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX.
Location
Telford, PA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Draeger Medical, Inc.. Units affected: 25 units.
Why was this product recalled? ▼
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 30, 2019. Severity: Critical. Recall number: Z-0740-2019.

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