Recall Z-2115-2019— Burlington Medical, LLC
Class II · Terminated
Class II FDA medical device recall by Burlington Medical, LLC, initiated 2019-06-07, terminated 2023-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M. Reason: 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..
- Recalling firm
- Burlington Medical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-07
- Terminated
- 2023-04-28
- Firm location
- Newport News, VA, United States
Product description
Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.