Reported Aug 21, 2024 · Ongoing
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd
- syringesCustomer Procedure Kit (Angiography/Angioplasty kit)
- REFTo support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures
170 of 170 codes
K09T-01138K09T-04484AK09T-04757FK09T-04835HK09T-07256DK09T-07588BK09T-07611KK09T-07649KK09T-07649LK09T-07649MK09T-09035HK09T-09035JK09T-09035MK09T-09035NK09T-09107KK09T-09319CK09T-09599QK09T-09672HK09T-09672JK09T-09843APK09T-10192BK09T-10405AK09T-10449K09T-10542GK09T-10790DK09T-10899CK09T-11052FK09T-11266BK09T-11305FK09T-11372GK09T-11496AK09T-11541BK09T-11831CK09T-11940AK09T-11940BK09T-12050DK09T-12292BK09T-12558DK09T-12624BK09T-13050FK09T-13097BK09T-13097CK09T-13232K09T-13257K09T-13335BK09T-13362AK09T-13362BK09T-13468AK09T-13469AK09T-13521CK09T-13595AK09T-13666K09T-13801K09T-14072AK09T-14106K10T-03350CK10T-04039FK10T-04245GK10T-04385GK10T-04448M
- Lot codes and dates
170 of 170 products
Products covered by this recall Model / number Barcodes Product as published K09T-0113800884450336007T2363424 T2386670 T2408156 T2480761 T2550174 T2571631 T2635757 T2640323 T2734947 T2774657 T2805967 T2833068 T2843260 T2850761 T2873975 T2885243 T2906058 K09T-04484A00884450566596T2816450 T2832465 T2854450 T2871539 T2901668 K09T-04757F00884450388396T2385183 T2434454 T2495466 T2525635 T2556829 T2584607 T2597014 T2640329 T2675582 T2708063 T2805969 T2843261 T2885245 T2895071 T2916416 K09T-04835H00884450270394T2287853 T2315252 T2349573 T2360340 T2386004 T2390911 T2414694 T2434737 T2449763 T2494448 T2587504 T2635754 T2667679 T2680871 T2712317 T2738104 T2781020 T2807074 T2833069 T2846966 T2864503 T2876387 K09T-07256D00884450603703T2360341 T2442955 T2498994 T2512482 T2560718 T2662053 T2745275 T2753062 T2800989 T2816846 K09T-07588B00884450264386T2205472 T2241180 T2314951 T2329404 T2349817 T2385184 T2386005 T2399751 T2442956 T2466089 T2479716 T2515708 T2536603 T2556831 T2560719 T2587556 T2606272 T2623834 T2657321 T2662059 T2690340 T2718870 T2748986 T2779872 T2800990 T2816851 T2846968 T2864504 T2874066 T2881132 T2906059 K09T-07611K00884450290392T2596860 T2652491 T2699218 T2699221 T2708069 T2717940 T2738107 T2762257 T2800991 T2833071 T2849220 T2883795 T2886087 T2939092 K09T-07649K00884450390627T2305612 K09T-07649L00884450644102T2339957 T2366225 T2386671 T2407056 T2417965 T2456584 T2495473 T2525638 T2550175 T2571768 T2594494 T2606278 T2640321 T2676814 K09T-07649M00884450763506T2712330 T2800995 T2805971 T2829278 T2846972 T2895076 T2913241 T2918196 K09T-09035H00884450390634T2305169 K09T-09035J00884450644119T2407057 T2417968 T2449348 T2456585 T2495474 T2525665 T2550176 T2587558 T2614918 T2640322 T2662061 T2676826 T2739363 K09T-09035M00884450783108T2774709 T2801082 K09T-09035N00884450801956T2832138 T2845195 T2850766 T2883742 T2886099 T2936006 K09T-09107K00884450388402T2333502 T2428903 T2457858 T2495482 T2551032 T2584608 T2643751 T2807078 K09T-09319C00884450336328T2333503 T2406792 T2426303 T2442997 T2479557 T2495485 T2525667 T2542381 T2570205 T2667684 T2676839 T2697309 T2726942 T2750320 T2779735 T2800998 T2805468 T2824416 T2899053 K09T-09599Q00884450305485T2657331 K09T-09672H00884450400142T2262333 T2322586 T2349973 T2370013 T2382254 T2390913 T2418132 T2428904 T2454371 T2471274 T2499030 T2525672 T2536622 T2550679 T2587433 T2606292 T2636536 T2676303 T2680820 T2708087 T2738112 T2786079 T2801005 T2823766 T2831465 K09T-09672J00884450806500T2843279 T2885516 T2898660 K09T-09843AP00884450396100T2634757 - Amount recalled
- 168157 kits
This recall covers 23 products
The agency filed one notice per product. You are reading one of them; the other 22 are below.
10 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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