Events

Recall of Device Recall InviroSnap

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inviro Medical Devices, 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
    55674
  • Event Risk Class
    Class 2
  • Event Number
    Z-1800-2010
  • Event Initiated Date
    2010-05-10
  • Event Date Posted
    2010-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91517
  • 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
    Syringe, antistick - Product Code MEG
  • Reason
    Syringe defects. group 1 syringes: the plunger pull out force was below specification. group 2 syringes: the needle length is out of specification.
  • Action
    Consignees were notified by letter on or about 05/10/2010. Consignees were instructed to review their inventory of InviroSnap Safety Syringes for the lot numbers and remove them from inventory and to return the affected product to Inviro Medical. They were instructed to pass on the information to anyone who uses or orders Inviro Snap Safety Syringes at their facility and to ensure a copy of the letter is provided to any other organizations to which affected devices have been transferred. A Response Card was included to be completed and faxed back to Inviro Medical Devices even if there is no product in inventory to verify receipt of notification. Questions regarding the recall were directed to the company's Customer Service number at (866) 914-2259. All product from Group 1 will be scrapped. Product from Group 2 will be retained in Quarantine until such time as the product can be exported the permission of the importing countries Ministry of Health.

Device

Device Recall InviroSnap
  • Model / Serial
    Group #1: Catalog number: 100002, Lot number: 2006-06; Catalog number: 100017, Lot number: 2006-09, Catalog number: 100018, Lot number: 2006-06 and 2006-08; Catalog number: 100019, Lot number: 2006-06, 2006-08, 2006-09 and 2006-10; Catalog number: 100032, Lot number 2006-07 and Catalog number: 100034, Lot number; 2006-10.   Group #2: Catalog number: 100019, Lot number: 2006-17, 061904, 062909, 063704 and 063804; Catalog number: 100032, Lot number: 2006-07 and 2006-08; Catalog number: 100038; Lot number: 061911, 062711 and 062811; Catalog number: 100047, Lot number: 2006-06, 2006-07 and 2006-15; Catalog number: 100055, Lot number: 062415.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, FL, IL, MI, MO, MN, NC, OH, TX; and Canada
  • Product Description
    InviroSnap¿ Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA.
  • Manufacturer
    Inviro Medical Devices, Inc

Manufacturer

Inviro Medical Devices, Inc
  • Manufacturer Address
    Inviro Medical Devices, Inc, 1755 N Brown Rd Ste 150, Lawrenceville GA 30043-8194
  • Manufacturer Parent Company (2017)
    Inviro Medical Devices, Inc
  • Source
    USFDA