Reported May 19, 2021 · Ongoing
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros…
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?
- REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning
- Spiros w/Red Cap - Product Usageprovides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)
- Lot codes and dates
- REFCL3946
- UDI(01) 1 0887709 08029 1 (17) 260101 (30) 50 (10) 5142959
- Lot Number5142959
This recall covers 26 products
The agency filed one notice per product. You are reading one of them; the other 25 are below.
13 more are in the archive.
Where it was sold
Why it was recalled
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
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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