Z-0738-2019 Class I Terminated
FDA device recall Z-0738-2019 was initiated by Draeger Medical, Inc. on Dec 21, 2018 and is designated Class I. Reason for recall: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit The recall status is terminated (terminated Apr 16, 2019). Affected quantity: 525 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 30, 2019
- Initiation Date
- Dec 21, 2018
- Termination Date
- Apr 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 525 units
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
Distribution Pattern
US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX.
Code Information
All Lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0738-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026