Events

Recall of Device Recall Infusion Pump Infusor SV and LV Elastomeric Infusion Devices

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
    65365
  • Event Risk Class
    Class 2
  • Event Number
    Z-1600-2013
  • Event Initiated Date
    2013-06-07
  • Event Date Posted
    2013-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118679
  • 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, elastomeric - Product Code MEB
  • Reason
    Baxter healthcare corporation (baxter) is issuing an urgent product recall for the products listed above due to an increase in rupture complaints. baxter has implemented product and process improvements which have substantially improved product quality. complaint rates for ruptures have since decreased. baxter wants to ensure that no affected product remains in the field.
  • Action
    An Urgent Product Recall notification was sent to all affected consignees on 06/13/2013. The letter states the affected products, problem description, hazard involved and actions to be taken by customer/user, with contact information. The letter was accompanied by a Customer Reply Form and a table of Affected Product List. The recall notification instructs customers to segregate affected product and contact Baxter for instructions for return of product.

Device

Device Recall Infusion Pump Infusor SV and LV Elastomeric Infusion Devices
  • Model / Serial
    Product Codes: 2C1008KP, 2C1009KP, 2C1063KP, 2C1087KP, 2C1156KP, 2C1700KP, 2C1702KP  Lot Codes: 10F032 10G056 10H066 10J047 10K024 10K087 10M021 10M088 10F059 10F069 10F070 10G029 10G043 10G062 10G067 10H032 10H093 10J049 10J060 10J089 10J105 10K028 10K030 10K038 10K088 10K096 10K102 10M025 10M044 10F022 10F068 10F072 10G030 10G045 10G046 10G047 10G050 10G051 10H016 10H018 10H087 10H094 10J053 10J058 10J062 10J102 10K026 10K035 10K039 10K086 10M023 10M040 10M043 10M045 10F020 10F087 10H086 10H095 10J017 10J020 10J056 10J068 10K021 10K029 10K031 10K081 10K105 10M017 10M039 10J052 10K098 10F064 10H044 10K022 10K042 10F024 10F025 10F033 10F055 10F062 10F063 10F065 10H005 10H030 10H042 10J015 10J019 10J061 10J065 10K032 10K037 10K095 10M030 10M087 10M098 10M099 10M100  Expiration Date: 06/30/13
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed Nationwide and in Puerto Rico.
  • Product Description
    Brand Name: Infusor SV and LV Elastomeric Infusion Devices. || Indicated for the intravenous administration of medications.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Route 120 And Wilson Rd, Round Lake IL 60073-9799
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA