Events

Recall of Pleatman Sac Tissue Removal System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Gyrus Acmi, Incorporated.

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
    56626
  • Event Risk Class
    Class 2
  • Event Number
    Z-2436-2010
  • Event Initiated Date
    2010-08-03
  • Event Date Posted
    2010-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94140
  • 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
    Laparoscope, General & Plastic Surgery - Product Code GCJ
  • Reason
    Gyrus medical, inc. has issued a urgent medical device recall for the gyrus acmi product 004942-903 - pleatman sac¿ tissue removal system, sold as lot 186540fc with an expiration date of 06/2015. as a result of a manufacturing error in the production of the trays used in this lot, it is possible that a crack could form that would compromise the package integrity, and possibly the sterility of th.
  • Action
    Gyrus Medical, Inc. of Maple Grove, MN issued an Urgent Medical Device Recall drawing attention to a possible package integrity compromise that could affect the product sterility. USA consignees were contacted via telephone on 8/3/10. The firm directed consignees to inspect their stock to confirm if any of the affected lot of product remains in their possession. Use of remaining affected product should cease immediately. Affected products should be return to Gyrus ACMI. For questions or concerns, consignees should contact the firm at (888) 524-7266.

Device

Pleatman Sac Tissue Removal System
  • Model / Serial
    lot 186540FC
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    UT, PA, Canada
  • Product Description
    The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while minimizing contamination of the abdominal cavity or wound tract. The system contains one (1) Sac and one (1) obturator in a sterile, ready -to -use, single- use procedure tray.
  • Manufacturer
    Gyrus Acmi, Incorporated

Manufacturer

Gyrus Acmi, Incorporated
  • Manufacturer Address
    Gyrus Acmi, Incorporated, 136 Turnpike Road, Southborough MA 01772-2118
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA