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

Recall Z-0105-2016 — CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061

U.S. FDA — Device Enforcement · United States · 2015-09-01 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0105-2016
Date of alert
2015-09-01
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
CooperSurgical, Inc.
Product category
device
Product type
Devices
Reported risk: Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)
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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