Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 11177...
FDA Device Recall #Z-2446-2018 — Class II — May 22, 2018
Recall Summary
| Recall Number | Z-2446-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 22, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | NewDeal SA |
| Location | St Priest |
| Product Type | Devices |
Product Description
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
Reason for Recall
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.
Distribution Pattern
CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI
Lot / Code Information
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
Other Recalls from NewDeal SA
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2447-2018 | Class II | TIBIAXYS, Model Numbers: 150010S, 150020S, 1500... | May 22, 2018 |
| Z-2443-2018 | Class II | UNI-CP, Model Numbers: 330021S, 330023S, 330025... | May 22, 2018 |
| Z-2445-2018 | Class II | ADVANSYS MLP/DLP, Model Numbers: 181051S, 18105... | May 22, 2018 |
| Z-2444-2018 | Class II | ADVANSYS TTC, Model Numbers: 181011S, 181012S, ... | May 22, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.