Burlington Medical leg wraps may lose radiation attenuation over time
Burlington Medical is recalling leg wraps because of the potential for attenuation degradation over time, decreasing the lifespan of the product.
What this means for you
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: degraded attenuation reduces the radiation protection the product is worn to provide, and no injuries are stated.
Plain-English summary
Burlington Medical is recalling its leg wraps. About 103 units were distributed nationwide in the United States and internationally to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay and Vietnam. The FDA has classified this recall as Class II.
There is potential for attenuation degradation over time, decreasing the lifespan of the product.
Affected product is identified in the FDA enforcement record.
Facilities can identify affected leg wraps by the product details above, and may contact Burlington Medical for further information.
The recalled product
- Product
- Burlington Medical, Leg Wraps.
- Manufacturer
- Burlington Medical, LLC
- Hazard
- attenuation-degradation
- radiation-exposure
- reduced-lifespan
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 (1)
- UDI-DI (Product Code): 00840331272147 (LGW8SET-U8LGW4).
Distribution
Distributed nationwide across the United States.
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