Events

Recall of Device Recall PHS (Professional Hospital Supply)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Rx Textiles 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
    26526
  • Event Risk Class
    Class 2
  • Event Number
    Z-1074-03
  • Event Initiated Date
    2003-06-11
  • Event Date Posted
    2003-08-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27838
  • 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
    unknown device name - Product Code : IPM
  • Reason
    Product may not be sterile.
  • Action
    Distributor was notified via email on 6/11/2003 and advised to quarantine the product. A follow up letter was sent via certified mail to the distributor and to the contract packer on 6/18/2003 with a questionnaire and a self addressed stamped envelope to verify effectiveness.

Device

Device Recall PHS (Professional Hospital Supply)
  • Model / Serial
    Lot #250512, Item #489150, 489230, 489267, 489305, 489310, 489347, 489433, 489374, 489412, 489427 and 499448. Lot #250514, Item #489150, 489230 and 489273.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was shipped to one distribution center in CA who shipped product to consignees located in CA and NV.
  • Product Description
    PHS, Tubular Stockinette Cotton, 6''x 48'' , 8''x 72'', 4''x 60'' and 4''x 48'' Double Ply, 6''x 72'', 4''x 48'' and 6''x 48''Single Ply and 4''x 4 YDS, 6''x 4 YDS and 3''x 4YDS, 1/pk 25 pk/cs, Manufactured for: Professional Hospital Supply, 41980 Winchester Rd, Temecula, CA 92590.
  • Manufacturer
    Rx Textiles Inc

Manufacturer

Rx Textiles Inc
  • Manufacturer Address
    Rx Textiles Inc, 3107 Chamber Drive, Monroe NC 28110
  • Source
    USFDA