Navilyst Medical, Inc recalls NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No. PK0604436S, ST…

Recall date

January 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1205-2015

FDA classification

Class II

Brand / firm

Navilyst Medical, Inc

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of: Canada, and Guam.

Why it was recalled

The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NAMIC Convenience Kit, LEFT HEART, POTENTIAL REVISION TO 600604412, UPN H965PK0604436S1, REF/Catalog No. PK0604436S, STERILE, Rx ONLY - For single use only. --- Device Listing Number D136588 NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.