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U.S. Department of Health and Human Services

Class 2 Device Recall Thyroid Collar Oversize,

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  Class 2 Device Recall Thyroid Collar Oversize, see related information
Date Initiated by Firm June 07, 2019
Date Posted July 30, 2019
Recall Status1 Terminated 3 on April 28, 2023
Recall Number Z-2130-2019
Recall Event ID 83144
Product Classification Apron, leaded - Product Code EAJ
Product 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.
Code Information 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 
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 2		 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 23
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.
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