Reported Aug 7, 2019 · Terminated
Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601XLM, RE601*M,…
Burlington Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Burlington Medical, LLC · PO Box 3194 · Newport News, VA · 23603-1137
Is this the product you have?
Frontal Quick Drop OR ApronProduct Number 601Part Numbers ECRE601AECRE601BECRE601CECRE601XLMRE601*MRE601CRE601D
- RE601XXLM Product UsageProducts are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user
- Lot codes and dates
- Serial Numbers
381792385576423909381833385669385700381810423908423907423936423938423910423939423906423913385705423627385664385671379711385670423911423915
- Serial Numbers
- Amount recalled
- 23
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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