FDA recall Z-1137-2023

Product

NovaStar TS, Anti-Asphyxia Valve, Reusable, Material Numbers MP01576 (Size S), MP01577 (Size M), and MP01578 (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

US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2023-01-23

Report date

2023-03-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1137-2023