Z-1954-2018 Class II Terminated
FDA device recall Z-1954-2018 was initiated by Draeger Medical, Inc. on Apr 26, 2018 and is designated Class II. Reason for recall: The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices. The recall status is terminated (terminated Sep 7, 2018). Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 6, 2018
- Initiation Date
- Apr 26, 2018
- Termination Date
- Sep 7, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
Reason for Recall
The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.
Distribution Pattern
Distributed to the states of CT, IL, MN, NV, SD, and WA.
Code Information
Serial nos. ASKM-0065 ASKM-0066 ASKM-0106 ASKM-0134 ASKM-0137 ASKM-0150 ASKM-0151 ASKN-0009
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1954-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026