FDA-Device2023-05-31Class II
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Windstone Medical Packaging, Inc.
Hazard
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
Sold states
US: MA OUS: None
Affected count
60 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1621-2023Don't want to check this manually?
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