Medical device recalls Moderate risk

Emergency Products & Research recalls O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.

Recall date
February 27, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1395-2024
FDA classification
Class II
Brand / firm
Emergency Products & Research
Sold / distributed
US Nationwide distribution in the states of CA, CO, FL, GA, IL, IN, KS, MA, MI, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WA.

Why it was recalled

Failure of adhesive to secure the pole insert.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.

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