medical Class II Updated 2022-04-20

Merit Medical Systems, Inc. recalls AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 58075

Recalled Product

AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

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: 580758001/P2073001; 580774001/I2219768; IN8152/C/H2292361, H2287442, H2281419, H2287443, H2298629, H2298630, H2305054, H2281405, H2305053, H2309362; K04-01197/H2296388; K05T-01863/T2313699; K09-09102B/H2308279; K09-10388A/H2285501; K09-12917/H2288582; K09-13501AP/H2265140; K10-05457AP/H2248304, H2265127, H2311255; K10-05635/H2285675, H2309893, H2305137; K10-05868P/H2278583; K10-05872P/H2275807, H2283595, H2309793, H2319811; K12-08303/H2266358, H2271477, H2295915 K12-10346/H2275972; K12-10375/H2290010; K12-10724AP/H2275826, H2299830; K12-10962/H2290113; K12-11413/H2262277, H2272368; MAP150/F/I2279928, I2259668; MAP152/B/P1908669, P1908670; MAP152/F/I2215502, I2259669, I2279933, I2289615, I2176727, I2289614, I2289616, I2279930; K12-01551/H2269831; K12-YP064A/H2288338, H2302500; K12-YP114/H2258787, H2288909, H2302503; K12-YP115/H2288352, H2302505; K12-YS047A/H2290278; IN8152/H2305053, H2305054, H2309362; K12-01551/H2269831
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