FDAJuly 6, 2020device
APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(10)4549203; (01)10887709070551(17)250101(30)50(10)4558619; (01)10887709070551(17)250101(30)50(10)4589971; (01)10887709...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
icu medicalicu
UPCs
10887709070551
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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