ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros"
Pending LLM rewrite. Source: FDA_DEVICE Z-0359-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
The recalled product
- Product
- ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot:14397353
- 14418912
- Distributed in Canada
Distribution
Distributed nationwide across the United States.
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