Reported Aug 21, 2024 · Ongoing

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C…

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
  • syringesK22C (Vein Tray Angiography kit)
  • REF

    124 of 124 codes

    • 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
    To support various vascular or cardiac diagnostic and interventional procedures
Lot codes and dates

124 of 124 products

Products covered by this recall
Model / numberBarcodesProduct as published
K09T-11796F00884450503508T2636554
K12T-01558G00884450352670T2329177 T2350727 T2371542 T2406796 T2430055 T2485419 T2540319 T2558850 T2574369 T2596749 T2637263 T2659470 T2716683
K12T-01558H00884450782934T2779744 T2823401 T2865508 T2909943
K12T-0182200884450048849T2329672 T2351649 T2366410 T2418145 T2479954 T2525431 T2544260 T2571995 T2635756 T2670966 T2716684 T2721174 T2738158 T2753461 T2781018 T2827635
K12T-01852L00884450390641T2627432
K12T-02006J00884450410912T2803003 T2866385 T2872131
K12T-0205400884450048917T2311048 T2323911 T2380682 T2383287 T2395389 T2427758 T2449372 T2464344 T2550262 T2609831 T2626139 T2697324 T2718897 T2753113 T2806098 T2832182 T2844200 T2866387 T2885324
K12T-02091G00884450265925T2458700 T2545242 T2587424 T2715273 T2736377 T2753117 T2780031 T2821698 T2888650 T2918566
K12T-02102B00884450352861T2597046 T2637278 T2662098 T2697333 T2751272 T2844211
K12T-0230900884450055007T2222971 T2331208 T2339980 T2405330 T2528876 T2560752 T2606584 T2697350 T2761529 T2821644 T2902935
K12T-02392A00884450242926T2144921 T2218464 T2244482 T2262003 T2296102 T2314800 T2339899 T2360807 T2416467 T2465735 T2509991 T2587265 T2637343 T2702608 T2776001 T2803012 T2821648 T2899061
K12T-0241600884450238684T2232553
K12T-02510N00884450558522T2616294 T2644061 T2776005 T2816289 T2886448
K12T-02725G00884450278260T2194607 T2303611 T2351004 T2408869
K12T-02725H00884450679500T2489997 T2587462 T2614079 T2655947 T2700183 T2713211 T2761550 T2781048 T2807148 T2906805
K12T-02890K00884450242209T2475031 T2570328 T2605749 T2626141 T2677852 T2704266 T2780036 T2803017 T2821647 T2823617 T2900194
K12T-02949A00884450049211T2449187 T2643784
K12T-03012C00884450518328T2232391 T2271357 T2305988 T2430292 T2540019 T2549960 T2560554 T2710204 T2776052 T2805520
K12T-03014B00884450518533T2193400 T2262009 T2283036 T2329184 T2428130 T2470356 T2540243 T2549961 T2560555 T2605751 T2697359 T2718786 T2805521 T2817191 T2899049
K12T-03058A00884450339459T2300687 T2352743 T2395547 T2428132 T2458769 T2544394 T2606612 T2776053
Amount recalled
103369 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.

Want the full recall guide?

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.