Events

Recall of Device Recall S.C.O.R.E.S Units

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

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
    73157
  • Event Risk Class
    Class 2
  • Event Number
    Z-1266-2016
  • Event Initiated Date
    2016-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143282
  • 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
    Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
  • Reason
    Water retention issues. units with filters that remain wet after the sterilization may compromised sterility.
  • Action
    On January 13, 2016 PMBS, LLC sent letters to their customers informing them of the correction. Per product's instructions for use, the SCORES cabinet is to be run for a minimun of a 4 minute sterilization cycle, followed by a 30 munites dry time followed by a 30 minutes door crack time. not all facilities generate completely dry SCORES filters following these instructions. It is imperative that the filters be checked in the Operation Room prior to useing the surgical instruments sterilised within the cabinet. If the filters are wet, do not use the contents. In the letter is a IFU addendum including instructions for running the equiptment with extended cycles. For more information please contact Ms. Michele Mauzerall, CEO at 908-300-7093.

Device

Device Recall S.C.O.R.E.S Units
  • Model / Serial
    ALL distributed S.C.O.R.E.S. units are affected.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL, GA, MN, NY, OH, OR SC, and TN
  • Product Description
    The S.C.O.R.E.S. Unit (self contained operating room equipment || sterilization unit)
  • Manufacturer
    PMBS, LLC

Manufacturer

PMBS, LLC
  • Manufacturer Address
    PMBS, LLC, 40 Milltown Rd, Stockton NJ 08559-1303
  • Source
    USFDA