Events

Recall of Device Recall ReliaMed Alginate/CMC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Medical Solutions Ltd..

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
    75033
  • Event Risk Class
    Class 2
  • Event Number
    Z-2720-2016
  • Event Initiated Date
    2015-01-15
  • Event Date Posted
    2016-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149165
  • 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
    Dressing, wound, drug - Product Code FRO
  • Reason
    On 08 january 2015 ams sole customer for the products notified ams of the issue after discovering the misplaced ifus during its review of packaging in its warehouse.
  • Action
    Advanced Medical Solutions' (AMS) Sole Customer has already received notification via telephone conference call, followed by emails and correspondence.

Device

Device Recall ReliaMed Alginate/CMC
  • Model / Serial
    51593 51772 52013 52001 52074 52668 52752 52756 52810 52851 53233 53234 53467 53655 53727 53685 53769 01129 01332 01569 02390 02584 02429 03696 03813 04095 04137
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    OH
  • Product Description
    ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
  • Manufacturer
    Advanced Medical Solutions Ltd.

Manufacturer

Advanced Medical Solutions Ltd.
  • Manufacturer Address
    Advanced Medical Solutions Ltd., Premier Park 33, Road One, Windford Industrial Estate, Winsford United Kingdom
  • Manufacturer Parent Company (2017)
    Advanced Medical Solutions Group Plc
  • Source
    USFDA