Reported Aug 22, 2018 · Terminated
PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check…
ICU Medical de Mexico, S.A. de C.V.
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 de Mexico, S.A. de C.V. · Avenida Cuarzo 250 · Ejido Maneadero · N/A
Is this the product you have?
- PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating Luer.
- Lot codes and dates
- Item Number011-AM6129. Lot Number 3459160, UDI Number (01) 1 0840619 09605 2 (17) 220501 (30) 01 (10) 3459160, Expiration Date 05/01/2022
- Amount recalled
- 30 pouches
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 more are in the archive.
Where it was sold
Why it was recalled
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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