O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
This recall is currently active, issued March 28, 2024. It was issued by Emergency Products & Research.
- Company
- Emergency Products & Research
- Recall Initiated
- February 27, 2024
- Posted
- March 28, 2024
- Recall Number
- Z-1395-2024
- Quantity
- 190,000 units
- Firm Location
- Kent, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Failure of adhesive to secure the pole insert.
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.
Lot / Code Info
Model EP-800; Lot No. 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, 122023-1.
Root Cause
Process control
Action Taken
Consignees were mailed an URGENT MEDICAL DEVICE RECALL notice, dated 2/27/24. The notice asked consignees who purchased product directly from the recalling firm to examine their inventory for affected devices, quarantine affected devices and discontinue use, and to follow the provided instructions for returning recalled product. Consignees who purchased their recalled devices through a third party are to examine their inventory for affected devices, quarantine affected devices and discontinue use, and contact the seller of the product to coordinate return. If a consignee is unsure of what third party a device was purchased from, they are to contact the recalling firm at 1-330-673-5003 or by email at EPRinfo@epandr.com. Customers may contact the recalling firm between the hours of 8:00 AM and 3:00 PM EST.