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
- syringesK12T/12PI (Custom Pressure Monitoring Kit)
- REFTo support various vascular or cardiac diagnostic and interventional procedures
K12-03846K12-04185AK12-03447K12M-02489K12-10056K12-02489AK12-02097BK12-12335K12-12192PK12-12079PK12-04262BPK12-11132BK12-12382K12-09098CK12-02112K12-02111K12-05576GK12-05805AK12T-10313CK12-11821PK12-01348DK12-11821K12-11426K12-06318K12-12053K12-03438K12-07208AK12-12147K12-09009K12-10375K12-08716K12-11669APK12-00657AK12-11131APK12-10914K12-07299PK12-05494K12-00443AK12-08303K12-06509AK12-10962K12-11133K12-06509B
- Lot codes and dates
43 of 43 products
Products covered by this recall Model / number Barcodes Product as published K12-02097B00884450191309H2413516 H2430266 H2448853 H2474037 H2505248 H2518159 H2540340 H2545409 H2575507 H2591235 H2744213 H2751673 H2846090 H2879948 H2912178 K12-02489A00884450191422H2407774 H2413469 H2520693 H2550452 H2566464 H2607157 H2705182 H2753896 H2758300 H2814926 H2850642 K12-0344700884450192443H2404130 H2408589 H2439003 H2451626 H2690274 H2757182 H2817430 H2846659 K12-0384600884450144848H2472033 H2494636 H2507902 H2536621 H2552837 H2557081 H2718140 H2810887 K12-04185A00884450193143H2398739 H2418369 H2557282 H2595087 H2635991 H2666462 H2690318 H2719739 H2775079 H2780258 H2792424 H2881789 H2916471 K12-04262BP00884450250426H2760748 H2784117 H2802626 H2829046 H2877237 H2897143 H2913395 K12-09098C00884450816509H2912500 H2912511 H2912512 H2912513 K12-1005600884450383704H2406238 H2418284 H2437885 H2469808 H2518359 H2529863 H2541614 H2555920 H2592114 H2659218 H2685221 H2709291 H2741843 H2767146 H2781349 H2795585 H2827702 H2845945 H2866232 H2875176 H2898026 K12-11132B00884450746530H2756363 H2762177 H2781251 H2818304 H2832627 H2866135 H2884335 H2931204 K12-12079P00884450652503H2760347 H2770070 H2778943 H2798363 H2808227 H2825288 H2838422 H2857759 H2867574 H2897171 H2905369 H2913161 K12-12192P00884450696118H2879420 H2885386 K12-1233500884450716328H2562551 H2591862 H2607163 H2615042 H2649774 H2705172 H2751359 H2763152 H2772980 H2810502 H2866204 H2871433 H2912338 K12-1238200884450767702H2819681 K12M-0248900884450092873H2405222 H2520692 H2800145 K12-00443A00884450190647H2757679 H2778135 H2796711 H2866277 H2905075 H2915547 H2926391 K12-00657A00884450190722H2535655 H2795577 H2810190 K12-01348D00884450190975H2383033 H2418832 H2436858 H2451479 H2495639 H2516727 H2520753 H2550062 H2557408 H2599531 H2729229 H2782335 H2836580 H2879389 K12-0211100884450400517T2616733 T2653219 T2709061 T2752964 T2821654 T2862633 T2899120 T2932790 K12-0211200884450400524T2587406 T2596839 T2653221 T2688030 T2718647 T2733013 T2775588 T2802964 T2827652 T2842314 T2899023 K12-0343800884450192412H2418283 H2489665 H2572196 H2659563 H2675954 H2747768 H2866235 H2881466 - Amount recalled
- 34197 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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