⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

ICU Medical, Inc.: ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

Medical DevicesSource: FDA (device) · Date: 2025-11-05

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
ICU Medical, Inc.
Product
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Reason / hazard
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Classification
Class II
Status
Ongoing
Distribution / sold at
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
2025-09-08
Code info
Lot:KL-VA001U3: 14360690 14345871 14367719 14381368 14381367; KL-VA002U3: 14345872; KL-VA131U3: 14381373; KL-VA201U3: 14337455 14381355 14381358; KL-VA202U3: 14367718, KL-VA321U3: 14345878 ; Distributed in Japan
Product quantity
202900 units
Voluntary mandated
Voluntary: Firm initiated
City
San Clemente
State
CA
Country
United States
Event id
97583
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