Z-1180-2021 Class II Terminated
FDA device recall Z-1180-2021 was initiated by Draeger Medical, Inc. on January 29, 2021 and is designated Class II. Reason for recall: Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient. The recall status is terminated (terminated November 1, 2021). Affected quantity: 25 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 17, 2021
- Initiation Date
- January 29, 2021
- Termination Date
- November 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 units
Product Description
ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
Reason for Recall
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
Distribution Pattern
US Nationwide distribution.
Code Information
All lots