Events

Recall of Prime Care, Prime Plus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Primus Medical 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
    68805
  • Event Risk Class
    Class 2
  • Event Number
    Z-2596-2014
  • Event Initiated Date
    2014-08-11
  • Event Date Posted
    2014-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128773
  • 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
    Cover, mattress (medical purposes) - Product Code FMW
  • Reason
    The firm found that the top cover of the mattresses were delaminating.
  • Action
    The firm sent out Urgent: Voluntary Field Correction/Removal letters, dated August 11, 2014, to all consignees with instructions for correcting the issue. Customers were to immediately examine their inventory and quarantine any affected product. Customers are to complete and return the response form provided. Questions can be directed to 1-877-638-2776.

Device

Prime Care, Prime Plus
  • Model / Serial
    Lot numbers: 031512, 032912, 041712,041812, 060412,061312, 061412, 071312, 080912, 032713, 053013, and 053113.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of TX, OH, PA, KS, FL, NV, IL, WA, MN, NJ, NC, UT, NY, CA, MD, CO. NE VA, and AZ; and, the country of Canada.
  • Product Description
    Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced Mattress, Prime Care ¿ Transcend Advanced Perimeter Mattress, Prime Plus ¿ Bariatric Mattress and Prime Plus ¿ Bariatric Perimeter Mattress, individual units packaged seperately. || Model Numbers: TCM3576, TCM3580, TCM3580P, TCM3584, TCM4280, TCM4280P, TCM4284, TACM3576, TACM3580, TACM3580P, TACM3584, PPBM396, PPBM426, PPBM426P, PPBM486, PPBM546, PPBM397, PPBM427, and PPBM487. || Intended to protect inner foam layers of mattress from any fluids that may be on the mattress.
  • Manufacturer
    Primus Medical LLC

Manufacturer

Primus Medical LLC
  • Manufacturer Address
    Primus Medical LLC, 8401 Southern Blvd, Boardman OH 44512-6709
  • Manufacturer Parent Company (2017)
    Primus Medical Llc
  • Source
    USFDA