Events

Recall of Device Recall Baxter Auto Syringe AS50 Infusion Pump

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

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
    34580
  • Event Risk Class
    Class 2
  • Event Number
    Z-0612-06
  • Event Initiated Date
    2006-02-07
  • Event Date Posted
    2006-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44132
  • 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
    A non-conforming gasket was used in manufacturing of the specific pumps, causing the pumps to be more susceptible to electro-static discharge, which could increase the potential for the pump to fail during use and alarm.
  • Action
    Baxter sent Urgent Device Correction letters dated 2/7/06 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for the affected pumps to be susceptible to electro-static discharge, which could increase the potential to fail during use, causing the pump to stop infusing and issue an audible and visual alarm. The accounts were asked to immediately take the pump out of service, contact Baxter at 1-800-843-7867 to arrange for the return of the pumps in order to replace the non-conforming gasket, and complete and return the enclosed reply form confirming receipt of the letter. Any questions were directed to the Center for One Baxter at 1-800-422-9837.

Device

Device Recall Baxter Auto Syringe AS50 Infusion Pump
  • Model / Serial
    serial numbers 15060001AB, 15060002AB, 15060004AB/15060013AB, 15060015AB/15060021AB, 15060023AB/15060073AB, 15060075AB, 15060077AB/15060116AB, 15060116AB, 15060118AB/15060126AB, 15060128AB/15060130AB, 15060132AB/15060172AB, 15060174AB/15060209AB, 15070003AB/15070006AB, 15070008AB/15070018AB, 15070021AB, 15070023AB, 15070026AB/15070034AB, 15070037AB15070041AB, 15070044AB/15070047AB, 15070049AB/15070052AB, 15070056AB/15070059AB, 15070066AB, 15070069AB, 15070071AB, 15070072AB, 15070076AB, 15070077AB, 15070079AB, 15070081AB, 15070082AB, 15070084AB, 15070086AB, 15070087AB, 15070092AB, 15070094AB/15070096AB, 15070099AB, 15070101AB, 15070109AB, 15070111AB/15070115AB, 15070117AB, 15070119AB, 15070121AB, 15070122AB, 15070124AB, 15070126AB/15070128AB, 15070130AB/15070132AB, 15070138AB/15070140AB, 15070144AB
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Arizona, California, Florida, Georgia, Hawaii, Iowa, Indiana, Kentucky, Louisiana, Michigan, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington, West Virginia
  • Product Description
    Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA