ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
Reported: November 5, 2025 Initiated: September 8, 2025 #Z-0340-2026
Product Description
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
Reason for Recall
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Details
- Recalling Firm
- ICU Medical, Inc.
- Units Affected
- 200 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.
- Location
- San Clemente, CA
Frequently Asked Questions
What product was recalled? ▼
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176. Recalled by ICU Medical, Inc.. Units affected: 200 units.
Why was this product recalled? ▼
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 5, 2025. Severity: Moderate. Recall number: Z-0340-2026.
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