FDA recall Z-0744-2019

Draeger Medical, Inc. · Class I · device

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-12-21
Report date
2019-01-30
Termination date
2019-04-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0744-2019