Events

Recall of Platelet Concentrator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew 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
    49129
  • Event Risk Class
    Class 2
  • Event Number
    Z-2446-2008
  • Event Initiated Date
    2008-08-05
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72817
  • 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
    Piston syringe - Product Code FMF
  • Reason
    Product contained a syringe whose package seal integrity can be adversely affected when the product is exposed to low atmospheric pressure. this may occur during shipping.
  • Action
    Prior to the dissemination of the official notices, the firm notified personnel at our field offices of the BD syringe recall and advised that a subsequent recall of our Caption devices would follow. High volume users were contacted via phone on July 30th and the 31st and personnel at all affected field offices were notified via email on July 30, 2008 with an Urgent Medical Device Recall Letter. The firm requedsted that usere immediately cease distribution, examin the stock on hand and the stock of the accounts that have been suppplied and remove any affected ecices from all inventory. A verification notification was included with letter

Device

Platelet Concentrator
  • Model / Serial
    Lot Nos.: 07EQT0003, 07EQT0004, 07EQT0005, 07JQT0003, 07KQT0002, 63207107, 07HM12429, and 07JM15582.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Manufacturer Address
    Smith & Nephew Inc, 1450 E Brooks Rd, Memphis TN 38116-1804
  • Source
    USFDA