Reported Aug 22, 2018 · Terminated
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light…
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?
- 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Valve, Clamp, Rotating Luer.
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published AM6128.a. — Lot Number 3423330, UDI Number (01) 1 0887709 08696 5 (17) 220401 (30) 50 (10) 3423330, Expiration Date 04/01/2022; b. — Lot Number 3476737, UDI Number (01) 1 0887709 08696 5 (17) 220601 (30) 50 (10) 3476737, Expiration Date 06/01/2022 - Amount recalled
- 150 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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