ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Reported: November 5, 2025 Initiated: September 8, 2025 #Z-0358-2026
Product Description
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
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
- 2450 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 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950. Recalled by ICU Medical, Inc.. Units affected: 2450 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-0358-2026.
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