Sterilmed, Inc. recalls Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a)…

Recall date

September 17, 2018

Source

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

Recall number

Z-0090-2019

FDA classification

Class II

Brand / firm

Sterilmed, Inc.

Sold / distributed

U.S. Nationwide distribution in the states of CA, CO, MN, and WA.

Why it was recalled

Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.

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

What was recalled

Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length), Product Code STJ408324