FDA Enforcement Class I Terminated

ID Circuit Watertrap (P) 180, Catalog Number MP01341 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.

Recall: Z-0742-2019 · Reported January 30, 2019

Enforcement

Recall Number
Z-0742-2019
Event ID
81874
Classification
Class I
Status
Terminated
Product Type
Devices
Firm
Draeger Medical, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
January 30, 2019
Initiation Date
December 21, 2018
Classification Date
January 24, 2019
Termination Date
April 16, 2019
Address
3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

Description

ID Circuit Watertrap (P) 180, Catalog Number MP01341 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

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

Code Info

All Lots

Distribution

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

Quantity

25 units