FDA (Devices) recall action 83144

Burlington Medical, LLC recalled 24 products on 2019-08-07

The FDA (Devices) publishes a recall like this one as 24 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 24 pages.

Products: 24
Announced: 2019-08-07
Critical: 0
Units: 4,420

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–24 of 24

HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Radiation Protection Hoods Due to Inadequate Shielding
Burlington Medical is recalling three radiation protection hoods because the protective material may not adequately shield users from scatter radiation.
Product
Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 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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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Frontal Radiation Protection Aprons Due to Inadequate Shielding
Burlington Medical is recalling Frontal Aprons with Quick Drop Velcro Closure because the protective material may provide inadequate protection against scatter radiation.
Product
Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing t
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection
Burlington Medical is recalling 23 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially increasing health risks for users.
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 redu
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Radiation Protection Aprons Due to Inadequate Shielding
Burlington Medical is recalling two radiation protection aprons because the protective material may provide inadequate shielding, potentially exposing users to scatter radiation.
Product
1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducin
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls 129 Full Overlap Radiation Protection Vests and Kilts
Burlington Medical is recalling 129 two-piece radiation protection vests and kilts because the protective material may provide inadequate shielding against scatter radiation.
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 per
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Radiation Protection Vests Due to Inadequate Shielding
Burlington Medical is recalling 22 radiation protection vests because the protective material may provide inadequate shielding against scatter radiation.
Product
Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, SEVESTA, SEVESTB, SEVESTC, UEVESTB, UEVESTXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary)
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Overlap Vests Due to Potential Inadequate Radiation Protection
Burlington Medical is recalling seven Overlap Vests because the protective material may provide inadequate protection against scatter radiation.
Product
Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Lead Apron Products Due to Inadequate Radiation Protection
Burlington Medical is recalling 332 lead apron products because the protective material may provide inadequate protection against scatter radiation.
Product
2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPVKE, UEPVK*F Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fl
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HighFDA (Devices)··2019-08-07
Burlington Medical Frontal Support Belt Apron Recalled for Inadequate Radiation Protection
Burlington Medical is recalling six Frontal Support Belt Aprons because the protective material may provide inadequate protection against scatter radiation.
Product
Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B, REF15XLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls 310 Full Wrap Vests and Kilts for Radiation Protection Defects
Burlington Medical is recalling 310 two-piece full wrap vests and kilts because the protective material may provide inadequate shielding against scatter radiation.
Product
2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECSEVKB, ECSEVKC, ECSEVKXLM, REVK*F, REVK*M, REVKB, REVKC, REVKE, REVKXXLM, SEVK*F, SEVK*M, SEVKB, SEVKC, SEVKE, SEVKF, SEVKG, SEVKXLF, SEVKXXLM, UEVK*F, UEVK*M, UEVKXXLF
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Frontal Apron Velcro Closures Due to Radiation Protection Concerns
Burlington Medical is recalling 104 Frontal Apron Velcro Closures because the protective material may provide inadequate protection against scatter radiation.
Product
Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF17*F, REF17*M, REF17XLF, REF17XLM, REF17XXLM, REF173XLM, UEF17A, UEF17M, UEF17*F, UEF17*M, UEF17XLF, UEF17XXLM Product Usage: Products are designed to protect healthcare workers
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection
Burlington Medical is recalling 807 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially increasing long-term health risks.
Product
Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4-T2T, SLTS4-R, UETS4-R Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while per
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Radiation Protection Caps Due to Inadequate Shielding
Burlington Medical is recalling 49 radiation protection caps because the protective material may not adequately shield users from scatter radiation.
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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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Half Aprons Due to Potential Radiation Protection Deficiency
Burlington Medical is recalling two half aprons because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to higher radiation levels.
Product
Half Apron, Product Number Half Apron, Part Numbers REHALF*, REHALF3 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
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Radiation Protection Aprons Due to Inadequate Shielding
Burlington Medical is recalling 48 radiation protection aprons because the protective material may provide inadequate shielding, potentially exposing users to scatter radiation.
Product
Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, REEURO*M, REEUROC, REEUROE, SEEURO*F, SEEURO*M, UEEURO*F Product Usage: Products are designed to protect healthcare workers against scatter
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HighFDA (Devices)··2019-08-07
Burlington Medical Porta Shield Radiation Protection Recall
Burlington Medical is recalling Porta Shield radiation protection products because the material may provide inadequate protection against scatter radiation.
Product
Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 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 reac
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection
Burlington Medical is recalling 2,190 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to increased health risks.
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 (se
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Radiation Protection Kilts Due to Inadequate Shielding
Burlington Medical is recalling 37 radiation protection kilts because the protective material may provide inadequate shielding against scatter radiation.
Product
Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEKILTC, SEKILT*F, SEKILT*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while p
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Radiation Protection Sleeves Due to Inadequate Shielding
Burlington Medical is recalling 39 radiation protection sleeves because the material may provide inadequate protection against scatter radiation.
Product
Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the am
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection
Burlington Medical is recalling 210 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to increased health risks.
Product
Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, SLTS5-R Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedure
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Full Wrap Support Belt Aprons Due to Radiation Risk
Burlington Medical is recalling 51 Full Wrap Support Belt Aprons because the protective material may provide inadequate protection against scatter radiation.
Product
1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111F, REF111*F, REF111*M, REF111B, REF111E, REF111F, SEF111*F, SEF111*M, SEF111C, SEF111D, SEF111E, SEF111F, UEF111*F, UEF111*M, UEF111A, UEF111B, UEF111C, UEF111D, UEF111E, UEF111XLM
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Frontal Quick Drop OR Aprons Due to Radiation Risk
Burlington Medical is recalling 23 Frontal Quick Drop OR Aprons because the protective material may provide inadequate protection against scatter radiation.
Product
Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601XLM, RE601*M, RE601C, RE601D, RE601XXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic an
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Seven Peak Vests Due to Inadequate Radiation Protection
Burlington Medical is recalling seven Peak Vests because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to higher radiation levels.
Product
Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE, SEPVEST*F Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount
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HighFDA (Devices)··2019-08-07
Burlington Medical Recalls Frontal Stretch Buckle Closure Aprons
Burlington Medical is recalling nine Frontal Stretch Buckle Closure Aprons because the protective material may provide inadequate protection against scatter radiation.
Product
Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B, REA10C, REA10*F, REA10*M, UEA10*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic pr
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