Z-2115-2019 Class II Terminated
FDA device recall Z-2115-2019 was initiated by Burlington Medical, LLC on June 7, 2019 and is designated Class II. 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 … The recall status is terminated (terminated April 28, 2023). Affected quantity: 7.
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2019
- Initiation Date
- June 7, 2019
- Termination Date
- April 28, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
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.
Distribution Pattern
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
Code Information
Serial Numbers: 385688 387953 385694 385696 387781 384424 382874