Home / Recalls / Medical Devices
Sterilmed, Inc. recalls Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart.
Recalled October 17, 2018 · FDA recall Z-0090-2019 · Sterilmed
Hazard
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing. · FDA Class II
Units
218 units
Sold at
U.S. Nationwide distribution in the states of CA, CO, MN, and WA.
Description
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Product
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
Manufacturer(s)
Sterilmed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →