Z-1395-2024 Class II Ongoing
FDA device recall Z-1395-2024 was initiated by Emergency Products & Research on February 27, 2024 and is designated Class II. Reason for recall: Failure of adhesive to secure the pole insert. The recall status is ongoing. Affected quantity: 190,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2024
- Initiation Date
- February 27, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190,000 units
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.
Distribution Pattern
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.