ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 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.
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S 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.
ICU Medical ChemoLock Closed Vial Spike REF: CL-80 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.
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 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.
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S 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.
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 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.
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 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.
ICU Medical ChemoLock Bag Spike REF: CL-10 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.
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176 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.
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173 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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