Reported Apr 20, 2022 · Ongoing
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863,…
Merit Medical Systems, Inc.
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: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- AccessPLUS Large Bore Hemostasis Valves
- Catalog Code
580758001580774001IN8152/CK04-01197K05T-01863K09-09102BK09-10388AK09-12917K09-13501APK10-05457APK10-05635K10-05868PK10-05872PK12-08303K12-10346K12-10375K12-10724APK12-10962K12-11413MAP150/FMAP152/BMAP152/FK12-01551K12-YP064AK12-YP114K12-YP115K12-YS047AIN8152K12-01551
- Lot codes and dates
28 of 28 products
Products covered by this recall # Product as published 1 Catalog Code/Lots: 580758001/P2073001 2 580774001/I2219768 3 IN8152/C/H2292361, H2287442, H2281419, H2287443, H2298629, H2298630, H2305054, H2281405, H2305053, H2309362 4 K04-01197/H2296388 5 K05T-01863/T2313699 6 K09-09102B/H2308279 7 K09-10388A/H2285501 8 K09-12917/H2288582 9 K09-13501AP/H2265140 10 K10-05457AP/H2248304, H2265127, H2311255 11 K10-05635/H2285675, H2309893, H2305137 12 K10-05868P/H2278583 13 K10-05872P/H2275807, H2283595, H2309793, H2319811 14 K12-08303/H2266358, H2271477, H2295915 K12-10346/H2275972 15 K12-10375/H2290010 16 K12-10724AP/H2275826, H2299830 17 K12-10962/H2290113 18 K12-11413/H2262277, H2272368 19 MAP150/F/I2279928, I2259668 20 MAP152/B/P1908669, P1908670 - Amount recalled
- 58963
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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