Z-1138-2023 Class I Ongoing
FDA device recall Z-1138-2023 was initiated by Draeger Medical, Inc. on January 23, 2023 and is designated Class I. Reason for recall: The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants. The recall status is ongoing. Affected quantity: 893 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 1, 2023
- Initiation Date
- January 23, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 893 units
Product Description
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)
Reason for Recall
The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.
Distribution Pattern
US Nationwide Distribution
Code Information
All Lot numbers. UDI-DI: 04048675040552 (MP01579); 04048675040569 (MP01580); 04048675040538 (MP01581)