FDAFDA · Food and drugs·Recall number Z-1395-2024
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Published April 3, 2024 · Recall initiated: February 27, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failure of adhesive to secure the pole insert.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Emergency Products & Research
- Distributor
- 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.
- Lot
- Model EP-800; Lot No. 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, 122023-1.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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