PlainRecalls
FDA Devices Critical Class I Ongoing

NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

Reported: March 1, 2023 Initiated: January 23, 2023 #Z-1138-2023

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.

Details

Recalling Firm
Draeger Medical, Inc.
Units Affected
893 units
Distribution
US Nationwide Distribution
Location
Telford, PA

Frequently Asked Questions

What product was recalled?
NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L). Recalled by Draeger Medical, Inc.. Units affected: 893 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 1, 2023. Severity: Critical. Recall number: Z-1138-2023.