Burlington Medical Porta Shield Radiation Protection Recall
Burlington Medical is recalling Porta Shield radiation protection products because the material may provide inadequate protection against scatter radiation.
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: The recall involves a risk-of-harm product where the protective material may be inadequate, potentially leading to long-term health conditions like cancer, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Burlington Medical, LLC is recalling nine units of Porta Shield products, including part numbers PTS2, PTS3, and PTS4. These products are designed to protect healthcare workers against scatter (secondary) radiation during fluoroscopic and radiographic procedures.
The recall was initiated because the protective material used in the manufacture of these products could potentially provide inadequate protection for the user. Using the products may expose users to scatter radiation of varying degrees depending on variables such as distance, shielding, position, time, and kV. Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
The products were distributed nationwide in the United States and to Korea and Thailand. Affected serial numbers include 419886, 443251, 426551, 443014, 444704, 416997, 391132, 419882, and 419877. Users should stop using these products and contact Burlington Medical for further instructions.
The recalled product
- Product
- Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation…
- Manufacturer
- Burlington Medical, LLC
- Affected units
- 9
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Burlington Medical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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