Recall Z-0738-2019— Draeger Medical, Inc.
Class I · Terminated
Class I FDA medical device recall by Draeger Medical, Inc., initiated 2018-12-21, terminated 2019-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: VentStar Basic (P) 180, Catalog Number MP00351 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.
- Recalling firm
- Draeger Medical, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-12-21
- Terminated
- 2019-04-16
- Firm location
- Telford, PA, United States
Product description
VentStar Basic (P) 180, Catalog Number MP00351 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.