Reported Nov 5, 2025 · Ongoing
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
- ICU Medical ChemoLock Vial Spike, 20mm
- REFCL-80S
- Lot codes and dates
- UDI
10887709069593/Lot:1437918214391979143953001440125414380121
- UDI
- Amount recalled
- 53,050 units
This recall covers 38 products
The agency filed one notice per product. You are reading one of them; the other 37 are below.
25 more are in the archive.
Where it was sold
Why it was recalled
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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