Emergency traction splint adhesive failure may compromise device function
Emergency Products & Research is recalling 190,000 O.T.D. traction splints because adhesive may fail to secure the pole insert, potentially compromising function in emergency medical situations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device with a structural defect (adhesive failure) that could affect device function. No injuries or hospitalizations have been reported in the source material, which aligns with the Score 3 criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Emergency Products & Research is recalling the O.T.D. Optimum Traction Device (Street Orange), a single-use traction splint, due to adhesive failure that may compromise device function. Approximately 190,000 units are affected.
The adhesive that secures the pole insert may fail during use. This defect could impact the device's ability to function properly in emergency medical settings.
The recalled devices (Model EP-800) were distributed nationwide in 19 states: California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Michigan, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia, and Washington. Affected lot numbers include 20230523-04, 09082023-11, 09082023-12, 122023-3, 122023-2, and 122023-1.
The recalled product
- Product
- O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
- Manufacturer
- Emergency Products & Research
- Affected units
- 190,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Model EP-800
- Lot No. 20230523-04
- 09082023-11
- 09082023-12
- 122023-3
- 122023-2
- 122023-1.
Distribution
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