Arrow International Inc recalls (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterizatio…

Recall date

December 22, 2017

Source

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

Recall number

Z-1331-2018

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

(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP