🍔 Food 💊 Drugs 🏥 Medical Devices
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950 Class II

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

ICU Medical, Inc. 20250908 Ongoing
Distributed: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
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ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 Class II

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

ICU Medical, Inc. 20250908 Ongoing
Distributed: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
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ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 Class II

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

ICU Medical, Inc. 20250908 Ongoing
Distributed: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
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ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17 Class II

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

ICU Medical, Inc. 20250908 Ongoing
Distributed: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
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ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20 Class II

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

ICU Medical, Inc. 20250908 Ongoing
Distributed: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
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ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955 Class II

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

ICU Medical, Inc. 20250908 Ongoing
Distributed: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
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ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 Class II

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

ICU Medical, Inc. 20250908 Ongoing
Distributed: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
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ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360 Class II

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

ICU Medical, Inc. 20250908 Ongoing
Distributed: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
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ICU Medical ChemoLock Port REF: CL2100 Class II

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

ICU Medical, Inc. 20250908 Ongoing
Distributed: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
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ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 Class II

Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

ICU Medical, Inc. 20250908 Ongoing
Distributed: Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
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