| |
Class 2 Device Recall Access9 Large Bore Hemostasis Valve |
 |
| Date Initiated by Firm |
March 01, 2022 |
| Create Date |
April 11, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0903-2022 |
| Recall Event ID |
89815 |
| Product Classification |
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
|
| 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,
|
| Code Information |
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;
|
Recalling Firm/
Manufacturer |
Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
|
| For Additional Information Contact |
801-253-1600
|
Manufacturer Reason
for Recall |
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.
|
FDA Determined
Cause 2 |
Component change control |
| Action |
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. |
| Quantity in Commerce |
36445 |
| 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
|
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
|
|
|
