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.
FDA Recall Z-2130-2019 · Posted 2019-07-30
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Recalling FirmBurlington Medical, LLC
Recall StatusTerminated
Product CodeEAJ
Date Initiated2019-06-07
Date Terminated2023-04-28
Product Quantity23
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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