Events

Recall of STORZ High Flow Insufflation Tubing (with filter)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Karl Storz Endoscopy.

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
    78289
  • Event Risk Class
    Class 2
  • Event Number
    Z-0098-2018
  • Event Initiated Date
    2017-10-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159075
  • 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
    Tubing/tubing with filter, insufflation, laparoscopic - Product Code NKC
  • Reason
    The label outside the cardboard box is labeled correctly but the pouches inside of some of the boxes were mislabeled as a different product.
  • Action
    The recalling firm issued letters flagged as 'SAFETY ALERT" dated 10/5/2017 via Federal Express on 10/10/2017.

Device

STORZ High Flow Insufflation Tubing (with filter)
  • Model / Serial
    Lot #129241
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution was made nationwide. There was government distribution and no military distribution. Foreign distribution was made to Canada.
  • Product Description
    STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer box), individually packaged in a sterile pouch (Catalog #20400161S), 10 pouches per cardboard box. Some of the pouches inside of cardboard box are incorrectly labeled as Catalog number 20400162S, High Flow Insufflation Tubing (with filter) For 26432020-1 THERMOFLATOR. The firm name on the label is Karl Storz Endoscopy-America, Inc., El Segundo, CA.
  • Manufacturer
    Karl Storz Endoscopy

Manufacturer

Karl Storz Endoscopy
  • Manufacturer Address
    Karl Storz Endoscopy, 2151 E Grand Ave, El Segundo CA 90245-5017
  • Manufacturer Parent Company (2017)
    Karl Storz SE & Co. KG
  • Source
    USFDA