VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/Anesthesia Sets with...
FDA Recall #Z-0741-2019 — Class I — December 21, 2018
Product Description
VentStar Anesthesia WT(P) 180, Catalog Number MP00374 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
Recalling Firm
Draeger Medical, Inc. — Telford, PA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
10 units
Distribution
US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX.
Code Information
All Lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated