Recall Z-2578-2024 ยท OEZ Cardiovascular Procedure Kit
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit (Angiography/Angioplasty kit), REF: K09T-01138 K09T-04484A K09T-04757F K09T-04835H K09T-07256D K09T-07588B K09T-07611K K09T-07649K K09T-07649L K09T-07649M K09T-09035H K09T-09035J K09T-09035M K09T-09035N K09T-09107K K09T-09319C K09T-09599Q K09T-09672H K09T-09672J
| Date | Aug 12, 2024 (initiated Jun 11, 2024) |
| Status | Open, Classified |
| Reason | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. |
| Root cause | No Marketing Application |
| Action | On 06/11/2024, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTICE" Letter to customers informing them that specific Merit Medical convenience kits contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. These syringes lack the appropriate/sufficient FDA market authorization. In addition, Merit Medical posted the Urgent Medical Device Recall letter and complete list of affected products/kits on their website at https://www.merit.com/products/documents/product-notices/. Customer are instructed to: 1. Immediately determine if any of the products identified in the |
| Quantity | 168157 kits |
| Distribution | U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.