Merit Medical Systems, Inc.: Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863

Hazard

Inflation device handle may detach from the syringe during procedure.

Details from the source

Reason for recall: Inflation device handle may detach from the syringe during procedure. Distribution: Worldwide - 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, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Br Quantity: 18,897 units Lot/code info: Reference Number/UDI/Lot Number: K05-00761F: 00884450294918 H2801768 00884450294918 H2872045 K05-01717B: 00884450139325 H2613573 00884450139325 H2650871 00884450139325 H2697189 00884450139325 H2736533 00884450139325 H2767978 00884450139325 H2787955 00884450139325 H2823896 00884450139325 H2844892 00884450139325 H2849102 00884450139325 H2854783 00884450139325 H2864807 00884450139325 H2869821 00884450139325 H2911094 00884450139325 H2920493 00884450139325 H2937574 00884450139325 H2980776 00884450139325 H3006229 00884450139325 H3030118 00884450139325 H3041746 00884450139325 H3068295 00884450139325 H3077898 00884450139325 H3096168 00884450139325 H3115553 00884450139325 H3125118 00884450139325 H3136596 00884450139325 H3147935 00884450139325 H3179116 00884450139325 H3191157 00884450139325 H3215391 00884450139325 H3227692 00884450139325 H3266089 00884450139325 H3324827 K05-02080D: 00884450141663 H3248072 K05-02090C: 00884450141687 H3079962 K05-02221: 00884450141878 H2867356 00884450141878 H3183526 K05-02338: 00884450139950 H2994406 K05-02470: 00884450140406 H3183534 K05-02954: 00884450298350 H2725969 K05-03094A: 00884450756102 I2725535 00884450756102 I3254468 K05T-00380C: 00884450286999 T2636525 00884450286999 T2697344 00884450286999 T2730359 00884450286999 T2745227 00884450286999 T2779731 00884450286999 T2792255 00884450286999 T2805457 00884450286999 T2842259 00884450286999 T2865498 00884450286999 T2916415 00884450286999 T2981465 00884450286999 T2985902 00884450286999 T3039943 008844

UPC codes

00884450294918, 00884450139325, 00884450141663, 00884450141687, 00884450141878, 00884450139950, 00884450140406, 00884450298350, 00884450756102, 00884450286999, 00884450140796, 00884450315347, 00884450142882, 00884450260166, 00884450140826, 00884450140833, 00884450095607, 00884450684023, 00884450814710, 00884450255803, 00884450463796, 00884450547915

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.