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

Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX — recall Z-2011-2012

U.S. FDA — Device Enforcement · United States · 2012-05-23 · Class II

As described by U.S. FDA — Device Enforcement: Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures powered by a high

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2011-2012
Date of alert
2012-05-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stingray Surgical Products, LLC
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - USA (nationwide)
Reported risk: On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to "Instructions For Use" of Bipolar Forceps not being cleared by FDA and incorrect "Instructions For Use" . The sterilization instructions have been altered without the clearance of the FDA.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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