Z-2128-2019 Class II Terminated
FDA device recall Z-2128-2019 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: 3.
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
- 3
Product Description
Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 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 reaching the user.
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: 419558 419557 414132