Merit Medical Systems, Inc. Recall 94797
Description: Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Merit Medical Systems, Inc. Recall 94797 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2574-2024 |
| Event ID | 94797 |
| Event Description | Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system. |
| Product Type | Devices |
| 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. |
| Quantity | 55305 |
| Recall 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. |
| Device Classification | 20240821 |
| Device Code Info | Catalog Number/UDI-DI code/Lot Numbers: PLS-1006/A 00884450467954 I2868407 I2873488 I2884101 I2889284 I2889285 I2889286 I2889287 I2889289 I2889288 I2903937 I2903938 I2903939 I2914399 I2925168 I2925169 PLS-1007/A 00884450467985 I2790541 I2862963 I2868410 I2868412 I2873489 I2882475 PLS-1008/A 00884450467992 I2868415 I2884088 I2889299 I2889300 I2661407S1 I2661408S1 I2925190 PLS-1009.5/A 00884450468036 I2862967 I2873494 I2889301 I2925173 PLS-1009/A 00884450468012 I2790564 I2873496 I2884103 I2889303 I2889306 PLS-1010.5/A 00884450468050 I2862970 PLS-1010/A 00884450468043 I2873497 I2873498 I2873499 I2873500 I2889327 PLS-1011/A 00884450468067 I2889329 PLS-2506/A 00884450468098 I2873501 I2889331 I2914419 PLS-2508/A 00884450468111 I2889334 PLS-2509/A 00884450468128 I2687649S1 I2868417 I2914426 PLS-2510/A 00884450468135 I2873503 I2889336 PLS-2511/A 00884450468159 I2889337 PLSX-1006/A 00884450489550 I2868420 I2873516 I2889355 I2914466 PLSX-1007/A 00884450489567 I2868421 I2873517 I2883775 I2903957 I2932677 PLSX-1008/A 00884450489574 I2889357 PLSX-1009/A 00884450489598 I2914468 |
| Center Classification Date | 20240812 |
| Recall Initiation Date | 20240611 |
| Recalling Firm | Merit Medical Systems, Inc. |
| Initial Notification | Letter |
| Similar To |