Events

Recall of Device Recall GemStar

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

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
    29056
  • Event Risk Class
    Class 2
  • Event Number
    Z-1077-04
  • Event Initiated Date
    2004-05-11
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33073
  • 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
    Pump, Infusion - Product Code FRN
  • Reason
    The firm's internal testing that revealed the potential air-in-line may go undetected when the set is used at temperatures above 25¿c (77¿ f).
  • Action
    Recall initiated May 11, 2004. Letters were sent to consignees and wholesalers.

Device

Device Recall GemStar
  • Model / Serial
    95-156-5H, 05-027-5H, 09-208-5H
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Total number of consignees that received product: 13. Five are wholesale dealers, None are distributors, 8 are retailers. Product has been distributed worldwide, and in the United States: AR, Washington DC, FL, IL, KY, LA, MA, MD, MN, MO, NJ, TX. Also sent to National Institute of Health, Bethesda, MD, (301) 496-4000
  • Product Description
    GemStar¿ I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271
  • Manufacturer
    Abbott Labs

Manufacturer

Abbott Labs
  • Manufacturer Address
    Abbott Labs, 755 Jarvis Dr, Morgan Hill CA 95037-2810
  • Source
    USFDA