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Recall Observatory FDA recall evidence

Device product

ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

Z-0353-2026

September 08, 2025

Class II

Product summary

Firm
ICU Medical, Inc.
Event
Event 97583
Status
Ongoing
Classification
Class II
Quantity
6450 units
Official record key
device-enforcement:Z-0353-2026

Official wording

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

Code information: UDI:10887709071411/Lot:14386086 14407433

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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