Reported Oct 28, 2020 · Terminated
20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case.…
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?
4 of 4 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | 10887709069203 | 20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709069203(17)250201(30)50(10)4742130 |
| 2 | 10887709069203 | (01)10887709069203(17)250401(30)50(10)4803158 |
| 3 | 10887709069203 | (01)10887709069203(17)250101(30)50(10)4558617 |
| 4 | 10887709069203 | (01)10887709069203(17)250101(30)50(10)4589967. The 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
- Lot Numbers
4742130480315845586174589967
- Lot Numbers
- 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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