Events

Recall of Device Recall TEM Disposable Tube Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Richard Wolf Medical Instruments Corp..

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
    35845
  • Event Risk Class
    Class 3
  • Event Number
    Z-1430-06
  • Event Initiated Date
    2006-07-07
  • Event Date Posted
    2006-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47013
  • 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
    Transanal Endoscopic Microsurgery System insufflation rectal cavity - Product Code HIF
  • Reason
    The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.
  • Action
    Richard Wolf field sales representatives telephoned the end users on 7/7/06, informing them that the blue connectors on the irrigation tube may be reversed in the tube set bundle for lot 060232 only. The end users were requested to return the affected lot of tubes for replacement at no charge, contacting Ms. Ellen Huffman at 800-323-9653, ext. 280 to make arrangements for the exchange of product. Any questions concerning the recall were directed to Ms. Huffman or Robert Casarsa at the same number.

Device

Device Recall TEM Disposable Tube Set
  • Model / Serial
    Part Number 4170.801, Lot Number 060232
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution --- including the states of Alabama, Florida, District of Columbia, Michigan, Minnesota, Nebraska, New York, Ohio, Oregon, Pennsylvania, Utah, Vermont and Wisconsin.
  • Product Description
    Tubing Set for TEM-Combined System; the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube; a sterile, disposable, single use accessory to the TEM (Transanal Endoscopic Microsurgery) System used for insufflation of the rectal cavity; Manufacturer: Richard Wolf GmbH, Postfoch 1164, D-75343 Knittlingen, Deutschland; Product Number 4170.801
  • Manufacturer
    Richard Wolf Medical Instruments Corp.

Manufacturer

Richard Wolf Medical Instruments Corp.
  • Manufacturer Address
    Richard Wolf Medical Instruments Corp., 353 Corporate Woods Pkwy, Vernon Hills IL 60061-3110
  • Manufacturer Parent Company (2017)
    Richard Und Annemarie Wolf Stiftung
  • Source
    USFDA