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

Recall Z-1599-2015 — VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.

U.S. FDA — Device Enforcement · United States · 2015-04-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1599-2015
Date of alert
2015-04-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien LLC
Product category
device
Product type
Devices
Reported risk: Possible sterility breach of the outer packaging (pouch) material which may compromise the outside surface sterility of the sealed inner tray.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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