Reported Jul 25, 2018 · Terminated

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

NewDeal SA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NewDeal SA · Immeuble Sequoia 2 97 A · St Priest · N/A

Is this the product you have?

  • Large QWIX
  • Model Numbers
    • 111740S
    • 111745S
    • 111750S
    • 111755S
    • 111760S
    • 111765S
    • 111770S
    • 111775S
    • 111780S
    • 111785S
    • 111790S
    • 111795S
    • 111800S
    • 111805S
    • 111810S
    • 111815S
    • 111820S
    • 121740S
    • 121745S
    • 121750S
    • 121755S
    • 121760S
    • 121765S
    • 121770S
    • 121775S
    • 121780S
    • 121785S
    • 121790S
    • 121795S
    • 121800S
    • 121805S
    • 121810S
    • 121815S & 121820S
Lot codes and dates

34 of 34 products

Products covered by this recall
#Product as published
1Lot # F6H4, F70W, F9B8, F9MY, FAJ6, FATG, FBHN, FC9D, FD33, FD34, FD35, FDQR, FDQS, FELG, FEW0, FF8X, FGA8, FGCS, FH80 111745S
2Lot # F6H5, F8S3, F9R8, FA4X, FAJ7, FB30, FBHP, FBRR, FBWE, FC0A, FE0C, FELH, FELJ, FEW1, FGCT & FHKY 111750S
3Lot # 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
4Lot # F5Q7, F6H6, F7VS, F7VT, F7VU, FAJ8, FATF, FBHR, FBRS, FCAL, FE0G, FE0H, FE0J, FELL, FELM, FF4W, FF90, FFVS, FFVT, FGCU, FH83 & FHCP 111760S
5Lot # 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
6Lot # 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
7Lot # F5QA, F6QQ, F70Y, F9E9, FA51, FA5L, FB32, FB3D, FBWQ, FE0V, FE0W, FE0X, FELN, FEW4, FF4Z & FFVZ 111775S
8Lot # F6HA, F70Z, F9B9, F9Z3, FA53, FB39, FBWG & FF50 111780S
9Lot # F61H, F710, F8S4-F9RQ, F9Z4, FA54, FB2A, FB33 & FBWH 111785S
10Lot # F61J, F6HB, F711, F8S5, F9N1, F9RR, F9Z5, FA55, FB2B, FBWJ, FBWJ/1 & FHCW 111790S
11Lot # F5QB, F712, F7W0, F7W1, F7W2, F9RS, F9Z6, FA56, FB2C, FB3A & FBWK 111795S
12Lot # F6HC, F7W3, F7W4, F9EA, F9RT, F9Z7, FA57, FBWL, FE0Y-FE0Z, FELP, FEW5 & FF52 111800S
13Lot # F5LE, F61K, F7W5, F7W6, F9R9, F9RA, F9Z8, FA58, FAP4, FB2D, FB3B, FBWM, FDQT, FDQU, FELQ, FELR, FEW6 & FGCW 111805S
14Lot # F5QC, F6HD, F8S6, F9PV, F9Z9, FA59, FAP5, FBWN, FD3G, FE10, FELS, FELT, FF55, FF93, FFW4, FH4V, FHL0 & FH4U 111810S
15Lot # E62H/G, F5LF, F7W7, F9PW, FATE, FBHU, FC0C, FD3H, FD3J, FE11, FELU, FELV, FF56, FFW5, FGA9 & FGCX 111815S
16Lot # F7RW, F7W8, F9EB, FAJ9, FBEA, FBRT, FD3K, FD3L, FE12, FELW, FEW7, FF57, FFW6 & FGCY 111820S
17Lot # E62K/G, F5LG, F7W9, F9EC, F9RB, FBHV, FC9E, FD3M, FD3N, FDQV, FELX, FELY, FELZ & FGAA 121740S
18Lot # F7WH, FAJD, FB2R, FBJ5, FD83, FE1F, FE1G, FEX3, FF9G & FGD4 121745S
19Lot # F6BV, F7WJ, F9BC, FAJE, FB2S, FBJ6, FC2J, FD84, FE1H, FE1J & FFX8 121750S
20Lot # F6HN, F7WK, F8YB, F9U8, FA4M, FAP7, FB2H, FBJ7, FC2K, FD85, FD86, FE1K, FE1L, FFX9, FFXA & FGD5 121755S

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 4, 2019 · Data as of Sep 19, 5:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.