Reported Oct 28, 2020 · Terminated
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10887709058757(17)250101(30)100(10)4573278…
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?
10 of 10 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | 10887709058757 | NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10887709058757(17)250101(30)100(10)4573278 |
| 2 | 10887709058757 | (01)10887709058757(17)250101(30)100(10)4590919 |
| 3 | 10887709058757 | (01)10887709058757(17)250201(30)100(10)4712217 |
| 4 | 10887709058757 | (01)10887709058757(17)241201(30)100(10)4537440 |
| 5 | 10887709058757 | (01)10887709058757(17)241201(30)100(10)4549906 |
| 6 | 10887709058757 | (01)10887709058757(17)250101(30)100(10)4559515 |
| 7 | 10887709058757 | (01)10887709058757(17)250201(30)100(10)4719743 |
| 8 | 10887709058757 | (01)10887709058757(17)250201(30)100(10)4726897 |
| 9 | 10887709058757 | (01)10887709058757(17)250201(30)100(10)4735597 |
| 10 | 10887709058757 | (01)10887709058757(17)241101(30)100(10)4461205. CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. . |
- Lot codes and dates
- Lot Numbers
4573278459091947122174537440454990645595154719743472689747355974461205
- 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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