Reported Oct 28, 2020 · Terminated
8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating Luer.1 unit per pouch, 50…
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?
8 of 8 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | 10887709062946 | 8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062946(17)250101(30)50(10)4603254 |
| 2 | 10887709062946 | (01)10887709062946(17)250201(30)50(10)4630684 |
| 3 | 10887709062946 | (01)10887709062946(17)250201(30)50(10)4718516 |
| 4 | 10887709062946 | (01)10887709062946(17)241201(30)50(10)4514832 |
| 5 | 10887709062946 | (01)10887709062946(17)241201(30)50(10)4537159 |
| 6 | 10887709062946 | (01)10887709062946(17)250101(30)50(10)4558447 |
| 7 | 10887709062946 | (01)10887709062946(17)250201(30)50(10)4724820 |
| 8 | 10887709062946 | (01)10887709062946(17)250201(30)50(10)4733554. 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
46032544630684471851645148324537159455844747248204733554
- 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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