Reported Aug 22, 2018 · Terminated
191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2…
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?
- 191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Clamp, Rotating Luer.
- Lot codes and dates
- Item Number 011-AM6125. Lot Number 3424313, UDI Number (01) 1 0840619 09486 4 (17) 220301 (30) 50 (10) 342313, Expiration Date 03/01/2022
- Amount recalled
- 50 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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