Events

Recall of Device Recall Bipolar Forceps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stingray Surgical Products, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62024
  • Event Risk Class
    Class 2
  • Event Number
    Z-2011-2012
  • Event Initiated Date
    2012-05-23
  • Event Date Posted
    2012-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109874
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    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.
  • Action
    Stingray Surgical Product sent an URGENT Instructions for Use Recall letter dated Mary 23, 2012, to all distributors. The letter identified the product, the problem, and the action to be taken by the client. Distributers were requested to convey the recall to their users along with fowarding copies of the firm's recall notification letter. IFU's will be destroyed or discarded by either user or distributor since returns will not be necessary. Distributors were asked to complete the form at the bottom of the letter and return via e-mail or fax. For questions clients were instructed to call 561-210-7582. For questions regarding this recall call 561-210-7582.

Device

Device Recall Bipolar Forceps
  • Model / Serial
    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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Product Description
    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 frequency generator.
  • Manufacturer
    Stingray Surgical Products, LLC

Manufacturer

Stingray Surgical Products, LLC
  • Manufacturer Address
    Stingray Surgical Products, LLC, 156 Nw 16th St, Boca Raton FL 33432-1607
  • Manufacturer Parent Company (2017)
    Stingray Surgical Products Llc
  • Source
    USFDA