FDAMarch 14, 2016device

Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for ...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.

What to do

FDA enforcement status: Terminated

Brands named

navilyst medical inc an angiodyamicsnavilystnavilyst medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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