O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Recall
- Recall Number
- Z-1395-2024
- Event Number
- 94207
- Firm
- Emergency Products & Research
- FEI Number
- 3002754225
- Product Code
- HSP
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- February 27, 2024
- Posted
- March 28, 2024
- Address
- 890 W Main St, Kent, OH, 44240-2284
Description
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Failure of adhesive to secure the pole insert.
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 [email protected]. Customers may contact the recalling firm between the hours of 8:00 AM and 3:00 PM EST.
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.
190,000 units