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

Recall Z-0721-2013 — Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulation, REF/Catalog No. 60-7523-001, Sterile, Rx ONLY -- CONMED CORPORATION, Electrosurgical, Cutting and Coagulation and Accessories.

U.S. FDA — Device Enforcement · United States · 2012-12-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0721-2013
Date of alert
2012-12-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ConMed Corporation
Product category
device
Product type
Devices
Reported risk: ConMed received complaints of some devices which had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products. In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use.
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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