FDA Recall Open, Classified

AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

Recall: Z-0904-2022 · Initiated March 1, 2022

Recall

Recall Number: Z-0904-2022
Event Number: 89815
Firm: Merit Medical Systems, Inc.
FEI Number: 1721504
Product Code: DTL
Status: Open, Classified
Root Cause: Component change control
Initiated: March 1, 2022
Address: 1600 W Merit Pkwy South, Jordan, UT, 84095-2416

Description

Reason

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.

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 [email protected]. 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 [email protected], 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.

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

Quantity

58963