Arrow International Inc recalls Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-…

Recall date

May 23, 2018

Source

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

Recall number

Z-2576-2018

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Puerto Rico

Why it was recalled

Product contains dry natural rubber latex. Label states Latex Free.

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

What was recalled

Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.