Arrow International Inc recalls ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Mult…

Recall date

December 22, 2017

Source

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

Recall number

Z-1333-2018

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

Why it was recalled

Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

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

What was recalled

ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions, PN: ASK-24301-GM; (5) Hemodialysis Catheterization Kit for High Volume Infusions, PN: CDC-25123-1A