Reported Oct 28, 2020 · Terminated
11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI
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?
11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI
3 of 3 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | 10840619059801 | ¿(01)10840619059801(17)250201(30)50(10)4718517 |
| 2 | 10840619059801 | (01)10840619059801(17)241201(30)50(10)4514500 |
| 3 | 10840619059801 | (01)10840619059801(17)250201(30)50(10)4727354. 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 Numbers
471851745145004727354
- 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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