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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0328-2026 - ChemoLock Bag Spike, 01 units
REF: CL-10-10
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2
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10/27/2025
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FEI # 2025816 ICU Medical, Inc.
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Z-0351-2026 - ICU Medical
21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector
REF: CL3360
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2
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10/27/2025
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FEI # 2025816 ICU Medical, Inc.
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Z-0332-2026 - ICU Medical
30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap
REF: CL3011
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2
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10/27/2025
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FEI # 2025816 ICU Medical, Inc.
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Z-0333-2026 - ICU Medical
30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger
REF: CL3511
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2
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10/27/2025
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FEI # 2025816 ICU Medical, Inc.
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Z-0359-2026 - ICU Medical
31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger
REF: CL3951
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2
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10/27/2025
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FEI # 2025816 ICU Medical, Inc.
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Z-0338-2026 - ICU Medical
45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer
REF: CL4151
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2
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10/27/2025
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FEI # 2025816 ICU Medical, Inc.
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Z-0361-2026 - ICU Medical
6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer
REF: CL4118
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2
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10/27/2025
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FEI # 2025816 ICU Medical, Inc.
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Z-0353-2026 - ICU Medical
6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port
REF: CL3955
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2
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10/27/2025
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FEI # 2025816 ICU Medical, Inc.
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Z-0339-2026 - ICU Medical
60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap
REF: CL4173
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2
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10/27/2025
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FEI # 2025816 ICU Medical, Inc.
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Z-0360-2026 - ICU Medical
7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter
REF: CL3967
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2
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10/27/2025
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FEI # 2025816 ICU Medical, Inc.
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