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

FDA Recall #Z-1395-2024 — Class II — February 27, 2024

Recall #Z-1395-2024 Date: February 27, 2024 Classification: Class II Status: Ongoing

Product Description

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

Reason for Recall

Failure of adhesive to secure the pole insert.

Recalling Firm

Emergency Products & Research — Kent, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

190,000 units

Distribution

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.

Code Information

Model EP-800; Lot No. 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, 122023-1.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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