Events

Recall of Device Recall Anchor Tissue Retrieval System TRS100SB

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Anchor Products Company, 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
    57432
  • Event Risk Class
    Class 2
  • Event Number
    Z-1590-2011
  • Event Initiated Date
    2010-12-09
  • Event Date Posted
    2011-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96202
  • 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
    The metal component within the unit can break and cause a malfunction. use of the device may represent a potential health hazard if the metal component is not removed after breakage.
  • Action
    The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their subrecall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535.

Device

Device Recall Anchor Tissue Retrieval System TRS100SB
  • Model / Serial
    Code TRS100SB, lots P05N, P07N, P11N, P13N, P19N, P20N, P23N, P25N, P29N, P30N, P31N, P34N, P37N, P41N, P42N, P43N, P44N, P46N, P47N, P48N, P49N, P51N, P52N, P53N, P55N, P56N, P57N, P58N, P60N, P61N, P66N, P68N, P69N, P71N, P75N, P78N, P85N, P90N, P94N, P94N, P96N, P98N, P99N, Q02N, Q04N, Q05N, Q06N, Q09N, Q11N, Q12N, Q13N, Q14N, Q17N, Q20N, Q23N, Q24N, Q30N, Q31N, Q36N, Q38N, Q41N, Q49N, Q50N and Q65N
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including state of: Missouri; and countries including: Australia, Belgium, Canada, France, Greece, Ireland, Japan, Spain and the United Kingdom.
  • Product Description
    Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS100SB || The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.
  • Manufacturer
    Anchor Products Company, Inc.

Manufacturer

Anchor Products Company, Inc.
  • Manufacturer Address
    Anchor Products Company, Inc., 52 W Official Rd, Addison IL 60101-4519
  • Manufacturer Parent Company (2017)
    Anchor Products Company
  • Source
    USFDA