Date Initiated by Firm |
June 07, 2019 |
Date Posted |
July 30, 2019 |
Recall Status1 |
Terminated 3 on April 28, 2023 |
Recall Number |
Z-2127-2019 |
Recall Event ID |
83144 |
Product Classification |
Apron, leaded - Product Code EAJ
|
Product |
Cap, Product Number Cap, Part Numbers CAP1, CAP2
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.
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Code Information |
Serial Numbers: 389083 423885 413884 417509 384253 378507 378503 378505 418959 418960 423897 423899 423893 423895 414395 419567 417515 417514 420508 385648 414155 420509 415418 420507 420501 409316 409320 409330 403879 403880 403882 403881 409310 404000 441028 441030 441022 441031 441027 442251 443572 441025 441024 443579 443574 431256 443575 431517 443573 |
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
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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 |
49 |
Distribution |
US Nationwide distribution.
The products were distributed to the following foreign countries: Korea, Thailand. |
Total Product Life Cycle |
TPLC Device Report
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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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