FDA-Device2023-05-31Class II
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
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
30 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1619-2023More Windstone Medical Packaging, Inc. recalls
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