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

Recall Z-1817-2017 — Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide

U.S. FDA — Device Enforcement · United States · 2016-10-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1817-2017
Date of alert
2016-10-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Micromedics, Inc.
Product category
device
Product type
Devices
Reported risk: The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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