ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF
Pending LLM rewrite. Source: FDA_DEVICE Z-0358-2026.
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 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
- 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:14393168
- 14414091
- Distributed in Canada
Distribution
Distributed nationwide across the United States.
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