Reported Oct 28, 2020 · Terminated
135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per…
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?
135 cm (53") Ext Set w/Remv 5 Gang StopcockBaseplate w/7 NanoClave4-Way StopcockRotating Luer1 Ext..1 unit per pouch25 pouches per case
- UDI(01)10840619060616(17)250201(30)25(10)4711366. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
- Lot codes and dates
- Lot Number4711366
- Amount recalled
- Total of all products (Listed #1 thru 101) = 304735 units
This recall covers 99 products
The agency filed one notice per product. You are reading one of them; the other 98 are below.
86 more are in the archive.
Where it was sold
Why it was recalled
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.
This product could cause temporary or reversible health problems — stop using it.
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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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