FDA Medical Device · Z-0357-2026

ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

Class II · Ongoing

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

Affected lots / codes — check yours against thisLot:14407070,14384996,14391949; Distributed in Canada

Recalling firm: ICU Medical, Inc., San Clemente, CA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 2000 units
Distribution: 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.
Recall initiated: September 8, 2025
Classified: October 27, 2025
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0357-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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