Calendar

Week of Sep 8, 2025

Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical ChemoLock Bag Spike REF: CL-10 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical ChemoLock Closed Vial Spike REF: CL-80 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ChemoLock Bag Spike, 01 units REF: CL-10-10 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing

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Sep 8, 2025device recall340d agoBeckman Coulter, Inc. device recall (Cls II)

MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. — Reason: Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. — Status: Ongoing

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Sep 8, 2025grant340d agoAVM BIOTECHNOLOGY, LLC — Immunomodulatory AVM0703 to bridge Relapsed/Refractory Diffuse Large B-Cell L...AVM Biotechnology LLC

CA grant. $992,425. PI: Theresa Deisher

Week of Sep 8, 2025