Events

Recall of BHIA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pml Microbiologicals 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
    39382
  • Event Risk Class
    Class 2
  • Event Number
    Z-0014-2008
  • Event Initiated Date
    2007-04-23
  • Event Date Posted
    2007-10-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55355
  • 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
    Microbiological media plates - Product Code JSO
  • Reason
    Plates manufactured without vancomycin. possibility for false resistant results.
  • Action
    On 4/23/07 the firm began contacting customers via fax and telephone.

Device

BHIA
  • Model / Serial
    Lot numbers 229957-1 and 229958-1
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    lot #229957-1: 120 plates were distributed to 9 Canadian consignees; 200 plates were shipped, quarantined, and destroyed at the Canadian distribution center. lot #229958-1: 110 plates were distributed to 9 US consignees; 210 plates were shipped, quarantined, and destroyed at the Canadian distribution center.
  • Product Description
    Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA || Catalog #P1174
  • Manufacturer
    Pml Microbiologicals Inc.

Manufacturer

Pml Microbiologicals Inc.
  • Manufacturer Address
    Pml Microbiologicals Inc., 27120 Sw 95th Ave, P.o. Box 570, Wilsonville OR 97070
  • Source
    USFDA