Events

Recall of RochesterPean Hemostatic Forceps 61/4, Curved, Sterile.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra York PA, Inc.

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
    75710
  • Event Risk Class
    Class 2
  • Event Number
    Z-0751-2017
  • Event Initiated Date
    2016-10-28
  • Event Date Posted
    2016-12-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151083
  • 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
    Forceps, general & plastic surgery - Product Code GEN
  • Reason
    The chevron seals of 6x10 tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
  • Action
    The firm, Integra, mailed an "URGENT MEDICAL DEVICE RECALL NOTICE" dated October 26, 2016 to customers affected by the recall to notify them of the issue. The notice described the product, problem and actions to be taken. The customers were instructed to immediately review their inventory to determine if they had any of the recalled product on hand and to discontinue distributing the product; review your customer traceability records for shipment of the product and forward a copy of this Recall Notice to any of your customers that purchased the affected lots; complete and return the Acknowledgement Form that accompanied the notice (even if you do not have any product(s)) by email to: FCA3@integralife.com or fax to: 1-609-750-4220. Should you have any questions regarding these instructions, please contact Customer Service at 1-866-854-8300.

Device

RochesterPean Hemostatic Forceps 61/4, Curved, Sterile.
  • Model / Serial
    Catalog # ST7-138; lot# 352
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution in NC and TX.
  • Product Description
    Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. || The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
  • Manufacturer
    Integra York PA, Inc

Manufacturer

Integra York PA, Inc