Class 2 Device Recall Thyroid Collar, Buckle Closure,

• Date Initiated by Firm: June 07, 2019
• Date Posted: July 30, 2019
• Recall Status: Terminated on April 28, 2023
• Recall Number: Z-2122-2019
• Recall Event ID: 83144
• Product Classification: Apron, leaded - Product Code EAJ
• Product: Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4-T2T, SLTS4-R, UETS4-R; ; 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.
• Code Information: Serial Numbers: 443646 419128 418103 418484 388010 376800 376806 419076 441180 441183 441186 441113 441181 441139 441136 441130 441131 441135 443748 423654 414987 420870 420877 443626 419123 388250 388245 383021 383032 381507 388123 381663 381508 376803 440957 440956 440966 433273 433267 440958 433270 414813 414814 414836 414837 414838 384534 388075 378637 414934 418310 418308 418302 418307 418303 383136 420902 424097 418102 418336 378749 409409 409435 381660 419139 383147 383145 419275 419274 418368 433348 408393 408010 408390 408316 409467 383081 388121 419246 424109 414884 408307 408322 408317 408313 408344 408330 408377 388248 378630 378638 378581 440846 433424 440842 441224 408308 408305 409448 408320 408310 408311 408323 408303 408312 408315 408306 408309 408340 408314 419043 383023 419074 431097 414823 424013 443695 443660 440979 443666 443651 443652 443648 443735 414896 419060 415987 415968 415965 415958 409372 415957 409430 409380 383259 414690 420357 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• Recalling Firm/ Manufacturer: Burlington Medical, LLC; PO Box 3194; 3 Elmhurst St; Newport News VA 23603-1137
• For Additional Information Contact: John Daspit; 757-968-5846
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Medical Device Recall notification letters were sent to customers on 6/7/19. Please take the following actions: Cease using recalled products immediately, quarantine the products, and prepare the products for return shipment to Burlington Medical. Contact Burlington Medical at (800) 221-3466 for specific return instructions. Note that Burlington Medical Customer Care will work with you to facilitate the return of recalled products, including by issuing you a Recall Tracking number. Burlington Medical will replace all recalled products at no cost to you. The replacement product will be the same size and model as the recalled product; if the same size and model is not available or has been discontinued, then Burlington Medical will replace the recalled product with a Burlington Medical product that is similar to the recalled product. Our Customer Care team will arrange for free shipment of the replacement product. If you have any questions, please call your Burlington Medical representative or Burlington Medical Customer Care at (800) 221-3466. The recall was expanded an additional Urgent Medical Device Recall notification letters were sent to customers on 7/3/19.
• Quantity in Commerce: 807
• Distribution: US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.