Class 2 Device Recall Thyroid Collar, Velcro Closure

• Date Initiated by Firm: June 07, 2019
• Date Posted: July 30, 2019
• Recall Status: Terminated on April 28, 2023
• Recall Number: Z-2121-2019
• Recall Event ID: 83144
• Product Classification: Apron, leaded - Product Code EAJ
• Product: Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R, RLTS2-SEP, RLTS2-T2T, SBTS2-R, SETS2-R, SLTS2-R, UETS2-R, UETS2-SEP, ULTS2-R, ULTS2-SEP; ; 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: 408295 388081 419292 419288 418098 418451 441111 441126 418276 414683 433375 418402 419210 376932 419356 424063 414941 418090 420827 420829 420824 418406 420882 422416 415855 408485 441114 441112 419019 378626 378642 419081 419342 419344 419345 406104 383177 383182 409423 408465 408432 408461 378560 414902 443732 433389 433390 433392 433326 433320 433324 433391 433377 433321 433318 443669 443728 443729 419064 418395 376802 378694 443934 440968 440887 388190 383019 383020 388027 409498 414539 414548 418201 418203 414938 420897 441203 414742 414686 414682 414681 414688 418295 386771 419253 420444 420446 420480 385447 419110 414981 419156 419115 419112 419157 385452 383166 383096 383097 383098 414748 388142 388146 388147 388150 417737 417736 418087 420316 409473 383106 383134 383135 418292 388059 422336 384664 384734 384733 384740 384679 383379 383152 383146 407620 408327 408328 428304 419338 388124 383150 387990 420289 383163 408388 408440 409495 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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: 2190
• 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.