Recall Z-2568-2024
Merit Medical Systems, Inc. · initiated June 11, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit), REF: K09T-11796F K12T-01558G K12T-01558H K12T-01822 K12T-01852L K12T-02006J K12T-02054 K12T-02091G K12T-02102B K12T-02309 K12T-02392A K12T-02416 K12T-02510N K12T-02725G K12T-02725H K12T-02890K K12T-02949A K12T-03012C K12T-03014B K12T-03058A K12T-03139 K12T-03203F K12T-03319 K12T-03321F K12T-03515 K12T-03560D K12T-03566H K12T-03638H K12T-03706A K12T-03746C K12T-03788 K12T-03839H K12T-03853C K12T-03866B K12T-03867A K12T-03868 K12T-03868A K12T-04068 K12T-04106D K12T-04106F K12T-04140J K12T-04586D K12T-04697 K12T-04959B K12T-04963A K12T-05061J K12T-05081D K12T-05093D K12T-05281C K12T-05334D K12T-05423G K12T-05442B K12T-05472H K12T-05559B K12T-05824G K12T-05824H K12T-05825H K12T-05926C K12T-05991A K12T-06033C K12T-06211B K12T-06250 K12T-06282 K12T-06374D K12T-06416A K12T-06561A K12T-06640C K12T-06732A K12T-06783B K12T-06819C K12T-06979B K12T-07003A K12T-07008G K12T-07088 K12T-07266A K12T-07305 K12T-07556C K12T-07614A K12T-07729A K12T-07845B K12T-07893B K12T-08003 K12T-08565A K12T-08614B K12T-08727B K12T-08801 K12T-08867 K12T-09267D K12T-09337A K12T-09438A K12T-09523A K12T-09595 K12T-09685 K12T-09875 K12T-09880A K12T-09889 K12T-09974A K12T-10167A K12T-10287 K12T-10338H K12T-10409 K12T-10733 K12T-11467 K12T-11524A K12T-12152A K12T-12456 K22C-00001 K22C-00001A K22C-00034 K22C-00035 K22C-00042 K22C-00043 K22C-00052 K22C-00053A K22C-00054A K22C-00056 K22C-00058A K22C-00059 K22C-00062A K22C-00064A K22C-00069 K22C-00069A K22C-00070 K22C-11010 To support various vascular or cardiac diagnostic and interventional procedures.
Codes / lots: Catalog Number/UDI-DI code/Lot Numbers: K09T-11796F 00884450503508 T2636554 K12T-01558G 00884450352670 T2329177 T2350727 T2371542 T2406796 T2430055 T2485419 T2540319 T2558850 T2574369 T2596749 T2637263 T2659470 T2716683 K12T-01558H 00884450782934 T2779744 T2823401 T2865508 T2909943 K12T-01822 00884450048849 T2329672 T2351649 T2366410 T2418145 T2479954 T2525431 T2544260 T2571995 T2635756 T2670966 T2716684 T2721174 T2738158 T2753461 T2781018 T2827635 K12T-01852L 00884450390641 T2627432 K12T-02006J 00884450410912 T2803003 T2866385 T2872131 K12T-02054 00884450048917 T2311048 T2323911 T2380682 T2383287 T2395389 T2427758 T2449372 T2464344 T2550262 T2609831 T2626139 T2697324 T2718897 T2753113 T2806098 T2832182 T2844200 T2866387 T2885324 K12T-02091G 00884450265925 T2458700 T2545242 T2587424 T2715273 T2736377 T2753117 T2780031 T2821698 T2888650 T2918566 K12T-02102B 00884450352861 T2597046 T2637278 T2662098 T2697333 T2751272 T2844211 K12T-02309 00884450055007 T2222971 T2331208 T2339980 T2405330 T2528876 T2560752 T2606584 T2697350 T2761529 T2821644 T2902935 K12T-02392A 00884450242926 T2144921 T2218464 T2244482 T2262003 T2296102 T2314800 T2339899 T2360807 T2416467 T2465735 T2509991 T2587265…
Reason for recall
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.
FDA-determined cause: No Marketing Application
Action taken
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 attached Customer Response Form (CRF) are within their facility, quarantine them, and discontinue use and distribution. 2. Ensure that appropriate 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 this notice is immediately shared with them. Additional distribution details may be required by health authorities. 4. Follow the attached instructions for placing the recall labels on the products containing Jiangsu Shenli syringes, which inform the users to not use the affected syringes. If additional recall labels are needed, contact Customer Service at (801) 208-4381. Product may be returned to inventory once properly over-labeled. 5.At the point of use, the Jiangsu Shenli syringes are to be discarded. Photographs of Jiangsu Shenli syringes are enclosed to assist in identification. 6.Post this URGENT MEDICAL DEVICE RECALL NOTICE and Jiangsu Shenli Syringe photographs on or near the affected products. 7.If replacement syringes are needed, contact Customer Service at (801) 208-4381 for recommended syringe suppliers. For questions contact Merit Sales Representative or Merit Customer Service at 801-208-4381, Hours: 6 am to 6 pm MST Mon.-Fri.
Details
- Recall number
- Z-2568-2024
- Initiated
- June 11, 2024
- Posted by FDA
- August 12, 2024
- Product code
- OEQ – Angiography/Angioplasty Kit
- Quantity
- 103369 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.
- Recalling firm
- Merit Medical Systems, Inc., South Jordan, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2557-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2558-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2559-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2560-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2561-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2562-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2563-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2564-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2565-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2566-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2567-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2569-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2570-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2571-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2572-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2573-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2574-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2575-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2576-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2577-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2578-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |
| Z-2579-2024 Class II | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | 06/11/2024Open, Classified |