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

Recall Z-0598-2014 — Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.

U.S. FDA — Device Enforcement · United States · 2013-11-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0598-2014
Date of alert
2013-11-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Asante Solutions, Inc.
Product category
device
Product type
Devices
Reported risk: Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
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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