Burlington Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
24
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2120-2019Class II1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52June 7, 2019
Z-2124-2019Class IIFrontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M June 7, 2019
Z-2113-2019Class IIVest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REJune 7, 2019
Z-2115-2019Class IIOverlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESJune 7, 2019
Z-2130-2019Class IIThyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTSJune 7, 2019
Z-2121-2019Class IIThyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-RJune 7, 2019
Z-2107-2019Class IIFrontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B, REA10C, REA1June 7, 2019
Z-2128-2019Class IIHood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to proJune 7, 2019
Z-2119-2019Class IIThyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTSJune 7, 2019
Z-2110-2019Class IIFrontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601XJune 7, 2019
Z-2116-2019Class II2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, June 7, 2019
Z-2125-2019Class IIFront/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROBJune 7, 2019
Z-2122-2019Class IIThyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-June 7, 2019
Z-2114-2019Class II2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKJune 7, 2019
Z-2112-2019Class II2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECJune 7, 2019
Z-2129-2019Class IIPorta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 Product Usage: ProductsJune 7, 2019
Z-2111-2019Class II1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111June 7, 2019
Z-2108-2019Class IIFrontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF1June 7, 2019
Z-2118-2019Class IIKilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILJune 7, 2019
Z-2123-2019Class IISleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL PrJune 7, 2019