Events

Recall of Device Recall remel Mueller Hinton Agar w/4 NaCl w/6 mcg/ml Oxacillin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remel, 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
    54042
  • Event Risk Class
    Class 2
  • Event Number
    Z-0644-2010
  • Event Initiated Date
    2009-12-08
  • Event Date Posted
    2010-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87309
  • 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
    Culture media, antimicrobial susceptibility test, mueller hinton agar/broth - Product Code JTZ
  • Reason
    The product may fail to adequately grow methicillin resistant staphylococcus aureus atcc 43300 and staphylococcus aureus atcc 33591.
  • Action
    The recalling firm issued two different recall letters dated December 8, 2009 via regular mail. One letter was addressed to Microbiology Laboratory Supervisor and the other to Distributors. Both letters explained the reason for recall, requested the customer discard all remaining units in their possession, and complete the enclosed Product Inventory Checklist to indicate the amount of product that was discarded. The letter issued to distributors also requests they notify their customers to the laboratory level and the Product Inventory Checklist has a block to be marked indicating they have notified their customers. Direct questions to the Technical Services Department at 1-800-255-6730 (United States) or 1-913-888-0939 (International).

Device

Device Recall remel Mueller Hinton Agar w/4 NaCl w/6 mcg/ml Oxacillin
  • Model / Serial
    Lot Number 833352, Exp. 2009.12.22.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS. || The product is a solid medium recommended for use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase-resistant penicillins (PRP, e.g. methicillin, nafcillin, and oxacillin).
  • Manufacturer
    Remel, Inc

Manufacturer

Remel, Inc
  • Manufacturer Address
    Remel, Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Source
    USFDA