NewDeal SA recalls Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755

Hazard / Issue

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

Issued by

FDA

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

Lot/Code Info: 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