Events

Recall of Device Recall Sterile Empty Vial (SEV)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Allergy Laboratories, 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
    74851
  • Event Risk Class
    Class 2
  • Event Number
    Z-2785-2016
  • Event Initiated Date
    2015-02-03
  • Event Date Posted
    2016-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148599
  • 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
    System, delivery, allergen and vaccine - Product Code LDH
  • Reason
    Potential for glass particles within the vials.
  • Action
    Allergy Laboratories notified the sole consignee via phone call on February 3, 2015. For further information, please call (405) 235-1451.

Device

Device Recall Sterile Empty Vial (SEV)

Manufacturer

Allergy Laboratories, Inc.
  • Manufacturer Address
    Allergy Laboratories, Inc., 1005 SW 2nd St, Oklahoma City OK 73109-1006
  • Source
    USFDA