medical Class II Updated 2022-04-20

Merit Medical Systems, Inc. recalls Access-9 Large Bore Hemostasis Valves, Catalog Code: 5807750

Recalled Product

Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F, K08-YP085A, K08-YS017B, K08-YS055A, K09-YS029A, K09-YS040F, K12-YP002A, K12-YP030A, K12-YP060A, K12-YP061A, K12-YP063C, K12-YP072, K12-YS018A, K12-YS019A, K12-YS026A, K05-01140D, K05-01706C***, K05-02595, MAP112, K05-00564L, K12-YP002A,

Hazard / Issue

A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in difficulty advancing the guidewire through the device. This defect may result in a delay of procedure.

Issued by

FDA

Affected States: MN, PA, AZ, FL, IL, AK, NY, CA, TX, KY, WI, NC, NJ, VA, CO, IN, AR, MO, LA, OR, MT, MA, MI, NE, WV, KS, MS, HI, IA, NH, ME, AL, DC, DE, NM, OH, GA, MD, TN, UT, RI, SC, OK, WA, ID, ND, SD, NV, VT
Lot/Code Info: Catalog Code/Lots: 580775001/I2219771, I2278741, I2226790; IN8112/C/H2292357, H2287440, H2281404, H2298626, H2305047, H2305048, H2309356; K05-00053H/H2305217; K05-00109G/H2304656; K05-00137K/H2304653; K05-00410G/H2305216; K05-00438G/H2309130; K05-00502F/H2309122; K05-00587D/H2309211; K05-01052/H2304607; K05-01706C/H2309133; K05-01880K/H2306962; K05-02130/H2304639; K05-02595/H2304614; K09-12599A/H2295450; K10-05487P/H2279857; K12-00264/H2285040; MAP111/F/I2259670, I2279884, I2259657, I2289610; MAP112/B/P1908667; MAP112/F/I2259661, I2279915, I2279894, I2176725, I2215955, I2289611, I2279895, I2289613, I2289612; K08-YP085A/H2249051, H2302394; K08-YS017B/H2249052; K08-YS055A/H2275990; K09-YS029A/H2266470, H2302474; K09-YS040F/H2286601; K12-YP002A/H2269321, H2278279, H2283742, H2295661; K12-YP030A/H2263653; K12-YP060A/H2272013; K12-YP061A/H2249088; K12-YP063C/H2272382, H2295556; K12-YP072/H2266224; K12-YS018A/H2284956; K12-YS019A/H2302506; K12-YS026A/H2276014, H2302507; K05-01140D/H2304611; K05-01706C/ (H2304610, H2309133)***; K05-02595/H2304614; MAP112/I2279895; K05-00564L/H2304617; K12-YP002A/H2295661;
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