AccessPLUS Large Bore Hemostasis Valves recall
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917…
Why was AccessPLUS Large Bore Hemostasis Valves recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917…
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 58963
- Distribution
- US: 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. OUS: Poland, Germany, France, United Kingdom, Belgium, Korea, Republic of, Austria, Canada, Spain, Luxembourg, Italy, Switzerland, Czech Republic, Netherlands, Japan, Honduras, Colombia, Greece, Ireland
- Recall date
- April 20, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)