Recall Z-2564-2024
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: K09/K09T (Custom Manifold Kit), REF: K09-00526L K09-00807AH K09-01467AD K09-01467AF K09-01514U K09-01734L K09-02040C K09-02683F K09-02804B K09-03844F K09-04088H K09-04088J K09-04863J K09-04946B K09-04998H K09-04998HP K09-05229JP K09-05342A K09-05375F K09-05939D K09-07759J K09-07789L K09-07789M K09-07828U K09-07828UP K09-07834C K09-07905G K09-08031D K09-08052Q K09-08065J K09-08150R K09-08423G K09-08493KP K09-08847A K09-08875B K09-09051H K09-09184B K09-09403HP K09-09481A K09-09499B K09-09814 K09-09900F K09-09902G K09-09902GP K09-09975 K09-10060F K09-10062F K09-10210A K09-10210B K09-10286G K09-10300F K09-10315B K09-10432A K09-10444J K09-10475 K09-10494C K09-10574D K09-10726 K09-10736D K09-10788A K09-10811 K09-10829B K09-10830C K09-10929 K09-10994D K09-11024DP K09-11076C K09-11107D K09-11149B K09-11196 K09-11207DP K09-11259G K09-11259GP K09-11444B K09-11482D K09-11607B K09-11646C K09-11913C K09-12030AP K09-12245A K09-12304A K09-12304B K09-12359B K09-12396FP K09-12404 K09-12556B K09-12615 K09-12698 K09-12698A K09-12699 K09-12699A K09-12699B K09-12704A K09-12867A K09-12899A K09-12939B K09-12939C K09-13082C K09-13171 K09-13228A K09-13337BP K09-13420 K09-13507CP K09-13617P K09-13659AP K09-13660 K09-13767 K09-13880 K09-13882 K09-13882A K09-13933 K09-14000 K09-14000A K09-14047 K09-14096 K09-14196 K09-14219 K09-14220 K09T-13643 To support fluid administration into the body. To support various vascular or cardiac diagnostic and interventional procedures.
Codes / lots: Catalog Number: K09-00526L UDI-DI code: 00884450410110 Lot Numbers: H2349153 H2383516 H2406764 H2413970 H2423156 H2448659 H2520716 H2575100 H2615198 H2703317 H2744465 H2756069 H2786999 H2795483 H2832682 H2866202 H2875102 H2925662 Catalog Number: K09-00807AH UDI-DI code: 00884450742365 Lot Numbers: H2746426 H2796444 H2796457 H2811125 H2824906 H2834319 H2846603 H2849847 H2875232 H2898333 H2898334 Catalog Number: K09-01467AD UDI-DI code: 00884450282441 Lot Numbers: H2361544 H2382954 H2412363 H2430072 H2450925 H2498356 H2518811 H2520081 H2542786 H2586501 H2641143 H2687299 H2758479 Catalog Number: K09-01467AF UDI-DI code: 00884450750575 Lot Numbers: H2663133 H2729165 H2782382 Catalog Number: K09-01514U UDI-DI code:00884450392539 Lot Numbers: H2369960 H2387656 H2425596 H2471303 H2506109 H2529512 H2564547 H2590002 H2616732 H2627662 H2666883 H2746432 H2770561 H2824896 H2841949 H2866790 H2897446 H2920615 Catalog Number: K09-01734L UDI-DI code:00884450585009 Lot Numbers: H2360817 H2387232 H2405472 H2442198 H2471391 H2488275 H2502884 H2528940 H2569420 H2587832 H2666928 H2676308 H2714908 H2740483 H2757855 H2780813 H2795414 H2809458 H2825037 H2837565 H2853628 H2890112 H2915671 Catalog Number:…
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-2564-2024
- Initiated
- June 11, 2024
- Posted by FDA
- August 12, 2024
- Product code
- OEZ – Cardiovascular Procedure Kit
- Quantity
- 188837 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-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-2568-2024 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 |