Reported Apr 20, 2022 · Ongoing
Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K,…
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?
- Access-9 Large Bore Hemostasis Valves
- Catalog Code
580775001IN8112/CK05-00053HK05-00109GK05-00137KK05-00410GK05-00438GK05-00502FK05-00587DK05-01052K05-01706CK05-01880KK05-02130K05-02595K09-12599AK10-05487PK12-00264MAP111/FMAP112/BMAP112/FK08-YP085AK08-YS017BK08-YS055AK09-YS029AK09-YS040FK12-YP002AK12-YP030AK12-YP060AK12-YP061AK12-YP063CK12-YP072K12-YS018AK12-YS019AK12-YS026AK05-01140DK05-01706C***K05-02595MAP112K05-00564LK12-YP002A
- Lot codes and dates
40 of 40 products
Products covered by this recall # Product as published 1 Catalog Code/Lots: 580775001/I2219771, I2278741, I2226790 2 IN8112/C/H2292357, H2287440, H2281404, H2298626, H2305047, H2305048, H2309356 3 K05-00053H/H2305217 4 K05-00109G/H2304656 5 K05-00137K/H2304653 6 K05-00410G/H2305216 7 K05-00438G/H2309130 8 K05-00502F/H2309122 9 K05-00587D/H2309211 10 K05-01052/H2304607 11 K05-01706C/H2309133 12 K05-01880K/H2306962 13 K05-02130/H2304639 14 K05-02595/H2304614 15 K09-12599A/H2295450 16 K10-05487P/H2279857 17 K12-00264/H2285040 18 MAP111/F/I2259670, I2279884, I2259657, I2289610 19 MAP112/B/P1908667 20 MAP112/F/I2259661, I2279915, I2279894, I2176725, I2215955, I2289611, I2279895, I2289613, I2289612 - Amount recalled
- 36445
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.
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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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