Medical device recalls High risk

Draeger Medical, Inc. recalls ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit…

Recall date
December 21, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0744-2019
FDA classification
Class I
Brand / firm
Draeger Medical, Inc.
Sold / distributed
US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

ID Circuit Basic 180, Catalog Number MP01350 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.

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