FDA recall Z-1621-2023

Product

Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

Reason for recall

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

Distribution

US: MA OUS: None

Key facts

Status

Ongoing

Initiation date

2023-04-24

Report date

2023-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billings, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1621-2023