FDA-Device2018-10-17Class II
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
Sterilmed, Inc.
Hazard
Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Sold states
U.S. Nationwide distribution in the states of CA, CO, MN, and WA.
Affected count
218 units
Manufactured in
5010 Cheshire Pkwy N Ste 2, Plymouth, MN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0090-2019Don't want to check this manually?
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