Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0090-2019 — 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 curv

U.S. FDA — Device Enforcement · United States · 2018-09-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0090-2019
Date of alert: 2018-09-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Sterilmed, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10888551044912

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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