Events

Recall of Device Recall Wound Closure Device

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

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
    70466
  • Event Risk Class
    Class 2
  • Event Number
    Z-1235-2015
  • Event Initiated Date
    2015-02-05
  • Event Date Posted
    2015-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133840
  • 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
    Tape and bandage, adhesive - Product Code KGX
  • Reason
    The manufacturers seal may not be present on the nylon pouch resulting in lack of assurance for sterility.
  • Action
    Zipline sent an Urgent Voluntary product Recall letters to customers on February 5, 2015 by e-mail with possible follow up on site by firm representatives. The letter identified the affected product, problem and actions to be taken. Customers are asked to quarantine inventory immediately and examine the affected lots for complete pouch seals. Any product found with an incomplete seal should be destroyed or returned to ZipLine Medical. Please complete the enclosed response form as soon as possible, even if you no longer have stock of the lot numbers subject to this correction. This information is required to reconcile the inventory. Please contact Customer Service at 1-888-326-8999 to coordinate any product returns, replacement stock, or credit notes.

Device

Device Recall Wound Closure Device
  • Model / Serial
    Lot 1002750, Exp 2016-09
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Panama, Tehran, Ireland, Sweden, Japan, Hong Kong, Finland, Pakistan, Taiwan, Malaysia.
  • Product Description
    Zip 8M Wound Closure Device; || for wounds up to 8 cm in length; || Product number PS9080; || Rx only, Sterile || Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
  • Manufacturer
    Zipline Medical

Manufacturer

Zipline Medical
  • Manufacturer Address
    Zipline Medical, 747 Camden Ave Ste A, Campbell CA 95008-4147
  • Manufacturer Parent Company (2017)
    Zipline Medical Inc.
  • Source
    USFDA