Reported Feb 17, 2021 · Terminated
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration…
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?
- 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE
- FILTER SetSource - Product UsageThe intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein)
- Lot codes and dates
- Model List NumberZ3532
- UDI(01)10887709033174(17)250401(30)50(10)4795091
- Lot Number4795091
- Amount recalled
- Total Kits = 7,500 for all four lots
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Due to the incorrect filter assembly.
This product could cause temporary or reversible health problems — stop using it.
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