Large QWIX recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

111740S - Lot # F6H4, F70W, F9B8, F9MY, FAJ6, FATG, FBHN, FC9D, FD33, FD34, FD35, FDQR, FDQS, FELG, FEW0, FF8X, FGA8, FGCS, FH80 111745S - Lot # F6H5, F8S3, F9R8, FA4X, FAJ7, FB30, FBHP, FBRR, FBWE, FC0A, FE0C, FELH, FELJ, FEW1, FGCT & FHKY 111750S - Lot # F70X, F7VP, F7VQ, F7VR, F9Z0, FA4Y, FAP1, FB38, FBHQ, FC0B, FD36, FD37, FD38, FE0D, FE0E, F7VR, F9Z0, FA4Y, FAP1, FB38, FBHQ, FC0B, FD36, FD37, FD38, FE0D, FE0E, FE0F, FELK, FEW2, FF16, FF4V, FF8Y, FF8Z, FFVR, FG3M, FG3N, FH82 & FHCM 111755S - Lot # F5Q7, F6H6, F7VS, F7VT, F7VU, FAJ8, FATF, FBHR, FBRS, FCAL, FE0G, FE0H, FE0J, FELL, FELM, FF4W, FF90, FFVS, FFVT, FGCU, FH83 & FHCP 111760S - Lot # F5Q8, F6H7, F6H8, F7VV, F7VW, F9Z1, FA4Z, FAP2, FB31, FB3C, FBHS, FBWP, FD39, FD3A, FD3B, FD3C, FE0K, FE0L, FE0M, FE0N, FE0P, FEW3, FF4X, FF91-FF92, FFVU, FFVV, FFVW, FGCV & FHCR 111765S - Lot # F5Q9, F6H9, F7VX, F7VY, F7VZ, F9Z2, FA50, FAP3, FB29, FBHT, FBWF, FD3D, FD3E, FD3F, FE0Q, FE0R, FE0S, FE0T, FE0U, FF4Y, FFVX, FFVY, FHCU & FHCV 111770S - Lot # F5QA, F6QQ, F70Y, F9E9, FA51, FA5L, FB32, FB3D, FBWQ, FE0V, FE0W, FE0X, FELN, FEW4, FF4Z & FFVZ 111775S - Lot # F6HA, F70Z, F9B9, F9Z3, FA53, FB39, FBWG & FF50 111780S - Lot # F61H, F710, F8S4-F9RQ, F9Z4, FA54, FB2A, FB33 & FBWH 111785S - Lot # F61J, F6HB, F711, F8S5, F9N1, F9RR, F9Z5, FA55, FB2B, FBWJ, FBWJ/1 & FHCW 111790S - Lot # F5QB, F712, F7W0, F7W1, F7W2, F9RS, F9Z6, FA56, FB2C, FB3A & FBWK 111795S - Lot # F6HC, F7W3, F7W4, F9EA, F9RT, F9Z7, FA57, FBWL, FE0Y-FE0Z, FELP, FEW5 & FF52 111800S - Lot # F5LE, F61K, F7W5, F7W6, F9R9, F9RA, F9Z8, FA58, FAP4, FB2D, FB3B, FBWM, FDQT, FDQU, FELQ, FELR, FEW6 & FGCW 111805S - Lot # F5QC, F6HD, F8S6, F9PV, F9Z9, FA59, FAP5, FBWN, FD3G, FE10, FELS, FELT, FF55, FF93, FFW4, FH4V, FHL0 & FH4U 111810S - Lot # E62H/G, F5LF, F7W7, F9PW, FATE, FBHU, FC0C, FD3H, FD3J, FE11, FELU, FELV, FF56, FFW5, FGA9 & FGCX 111815S - Lot # F7RW, F7W8, F9EB, FAJ9, FBEA, FBRT, FD3K, FD3L, FE12, FELW, FEW7, FF57, FFW6 & FGCY 111820S - Lot # E62K/G, F5LG, F7W9, F9EC, F9RB, FBHV, FC9E, FD3M, FD3N, FDQV, FELX, FELY, FELZ & FGAA 121740S - Lot # F7WH, FAJD, FB2R, FBJ5, FD83, FE1F, FE1G, FEX3, FF9G & FGD4 121745S - Lot # F6BV, F7WJ, F9BC, FAJE, FB2S, FBJ6, FC2J, FD84, FE1H, FE1J & FFX8 121750S - Lot # F6HN, F7WK, F8YB, F9U8, FA4M, FAP7, FB2H, FBJ7, FC2K, FD85, FD86, FE1K, FE1L, FFX9, FFXA & FGD5 121755S - Lot # F6HP, F7WL, FAJF, FB2J, FBJ8, FBRV, FC2L, FD87, FE1M, FE1N, FF9H, FFXB & FHL1 121760S - Lot # F6HQ, F7WM, FAH2, FB2V, FB88, FBJ9, FD89, FE1P, FE1Q, FEX4, FHDB & FHDB/1 121765S - Lot # F6HR, F8BW, F9U9, FB2T, FBJA, FD8A, FD8B, FE1R, FE1S, FFXC & FH84 121770S - Lot # F64T, F6HS, F7WW, F9RD, FA4N, FB2W, FBWT, FE1T, FFXD, FH85 & FH85/1 121775S - Lot # F6HT, F8YC, F9PX, F9UA, F9ZD, FA4P, FBWU, FDQW, FDQX, FDQY, FDQZ, FE1U & FFXF 121780S - Lot # F6HU, F7JQ, F9UB, FA4Q, FAP8, FBJB, FBWV, FC2M, FDR0, FDR1, FDR2 & FDR2/1 121785S - Lot # F60U, F6HV, F7WN, FAJG, FBJC, FD8C, FD8D, FD8E, FE1V, FEX5, FH54 & FH54/1 121790S - Lot # F8YD, FB2X, FCAJ, FE1W, FEX6, FFXG & FH86 121795S - Lot # F6HW, F7BH, FBRW, FCCC, FE1X, FE1Y, FF9K, FGAC & FHDE 121800S - Lot # F6AR, FCAM, FD8F, FE1Z, FF9L, FF9M, FH55, FH87 & FH87/1 121805S - Lot # F6HX, F9FN, FCAK, FE20, FF9N & FGD6 121810S - Lot # F5LK, F7WP, F9RE, FD8G, FE21, FEX7, FF9P & FFXH 121815S - Lot # F7WQ, FBJD, FCCD, FD8H, FE22, FF9Q, FF9R & FGAD 121820S - Lot # F9BD, FBJE, FD8J, FD8K, FE23, FF9S & FG3P

Product

Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S…

Recalling firm

NewDeal SA

Distribution

CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI

Recall date

July 25, 2018

Classification

Class II

Status

Terminated

Agency

FDA (device)