Burlington Medical recalls 2 pc Full Wrap Vest & Kilt Back-Savers due to potential inadequate radiation protection, increasing cancer and infertility risks from scatter radiation exposure during medical procedures.
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Burlington Medical is recalling 2-piece Full Wrap Vest and Kilt Back-Savers because the protective material might not shield users from scatter radiation during medical procedures. Long-term exposure could raise cancer, infertility, or other health risks.
The vests' protective material may not adequately block scatter radiation generated during medical imaging. Prolonged exposure to this radiation can increase the risk of cancer, infertility, or other health issues over time.
Healthcare workers using these vests during fluoroscopy or radiography procedures are most at risk. The recall affects specific models sold with serial numbers listed in the notice.
Check for the product name '2 pc Full Wrap Vest & Kilt Back-Saver', Product Number PVK, and the listed serial numbers (e.g., 381795, 385536, etc.) on the device.
Look for the serial numbers listed in the recall notice (e.g., 381795, 385536) on the device.
The protective material in the vests may not provide adequate radiation shielding, potentially increasing cancer, infertility, or other health risks from scatter radiation exposure during medical procedures.
Check the product's serial number against the list provided in the recall notice. If it matches, stop using it and contact Burlington Medical for further instructions.
The recall states long-term exposure may increase health risks, but the hazard does not involve immediate serious injury or death. The danger level is low risk.
We’ve drafted a message you can send Burlington Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2116-2019 — Burlington Medical Burlington Medical Hello, I own a Burlington Medical that is covered by recall Z-2116-2019 from Burlington Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
