ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
Reported: November 5, 2025 Initiated: September 8, 2025 #Z-0332-2026
Product Description
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
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
- 11000 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 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011. Recalled by ICU Medical, Inc.. Units affected: 11000 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-0332-2026.
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