—#192626

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,

FDA product code: DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
Affected 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;

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.

Root cause (FDA determination)

Component change control

Action the firm took

On 03/01/22, recall notices were mailed to customers wo were informed to take the following actions: 1. Quarantine and discontinue use, and distribution of affected devices. 2. Ensure that applicable personnel within their organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, ensure the recall notice is immediately shared with them and note the quantity distributed on the Customer Response Form. 4. Fill out, scan, and email the completed Customer Response Form to Customer Service at response@merit.com. All affected product shipped to you must be accounted for on the Customer Response Form. 5. Immediately return all affected lots to the recalling firm. Customers with additional questions are encouraged to contact a sales representative or the firm s customer service at RESPONSE-EMEA@merit.com, 1-800-356-3748, Hours: 6 am to 6 pm MST, Mon-Fri. Recall notices were also sent to Sales representatives who were asked to contact their affected accounts and assist with product return and completion of the Customer Response Form. On 03/21/22, recall notices and response forms including an expanded scope were sent to customers informing them of additional distributed amounts of affected devices.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2022-03-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192626. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.