Z-2114-2019Class II

2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVKF, REFVKM, REFVKB...

Name: Z-2114-2019 2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB...
Creator: Burlington Medical, LLC
Published: 2019-06-07
License: https://open.fda.gov/license/

Burlington Medical LLC / initiated 2019-06-07 / Terminated / root cause: manufacturing process

FDA source

Burlington Medical, LLC began a recall of 2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE... on 2019-06-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2114-2019
Classification: Class II
Status: Terminated
Initiated: 2019-06-07
Posted: 2019-07-30
Terminated: 2023-04-28
Recalling firm: Burlington Medical LLC
Product: 2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM 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.
Product code: EAJ Apron, Leaded
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.
Root cause tag: manufacturing process
FDA root 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: 129
Distribution: US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
Product codes and lots: Serial Numbers: 382915 418869 443152 443303 443314 443116 443309 443122 443190 443115 385698 387994 387972 423969 381793 419868 385687 414095 419532 391154 423565 387997 385699 387917 382841 382946 382824 391134 384324 382787 381796 418843 387119 384454 384420 391099 382998 391096 382816 382909 423746 423667 382819 381798 384421 381821 384336 381828 385580 384349 423530 418903 423531 423976 419873 382859 418830 391146 419862 387967 418955 385691 391138 385680 385532 385692 387900 382782 384402 382823 382818 391163 382857 382866 382838 382906 381939 382995 381808 382903 391091 391164 381807 382862 418886 391148 418885 385690 391088 385681 391086 385682 391088 384412 381917 384422 384394 443131 443310 382900 385600 385693 391136 385683 391080 384294 384425 423945 387969 444689 443128 381790 418894 385686 391135 385684 385731 385689 381942 443104 444591 387974 419843 443129 443300 417565 391145 382850 382931

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2114-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2107-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2108-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2109-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2110-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2111-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2112-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2113-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2114-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2115-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2116-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2117-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2118-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2119-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2120-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2121-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2122-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2123-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2124-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2125-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2126-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2127-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2128-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2129-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30
Z-2130-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-07	2019-07-30

Product code EAJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)