Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T 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.
Enforcement
- Recall Number
- Z-2130-2019
- Event ID
- 83144
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Burlington Medical, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 7, 2019
- Initiation Date
- June 7, 2019
- Classification Date
- July 30, 2019
- Termination Date
- April 28, 2023
- Address
- PO Box 3194, 3 Elmhurst St, Newport News, VA, 23603-1137, United States
Description
Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T 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.
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.
Serial Numbers: 383071 418435 384523 379009 441088 441042 404378 383337 407642 375480 383073 383072 383186 420487 441239 414699 414689 414685 414702 414741 414692 388017 383269
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
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