Events

Recall of Device Recall Infusion Pump SV Elastomeric Infusion Device

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-1605-2013
  • 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=119109
  • 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
    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 SV Elastomeric Infusion Device
  • Model / Serial
    Product Codes: 2C1071KJP, 2C1073KJP, 2C1075KJP  Lot Codes: 08J078 08K002 08K005 08K007 08K054 08K066 08M001 08M025 08M028 08M039 08N003 08N005 08N032 09A004 09A040 09A042 09A064 98025 98027 98028 98070 09(018 09C023 09(024 09C045 09C047 09(075 90029 90031 90033 90065 90069 90086 09E026 09E027 09E031 09F023 09F024 09F025 09F040 09F041 09F042 09G013 09G061 09G062 09H004 09H008 09H035 09H036 09H070 09H082 09J006 09J007 09J074 09J075 09K017 09K018 09K021 09K022 09K086 09K087 09M002 09M005 09M037 09M038 09M039 09M078 09N027 09N028 09N029 09N034 10A019 10A020 10A021 10A044 108010 108029 10C002 10C003 10C006 10C078 10C079 10C099 10C103 10C111 100026 100027 100028 100058 100062 100063 10E003 10E008 10E009 10E067 10G005 10G006 10G007 10G008 10G078 10G079 10H014 10H019 10H020 10H022 10H054 10H056 10H057 10H060 10H069 10H071 10H105 10H107 10J022 10J023 10J026 10J028 10J029 10J070 10J071 10J074 10K043 10K044 10K047 10K049 10K051 10K061 10K065 10K110 10M056 10M058 10M059 10M060 10N006 10N024 10N028 10N078 11A022 11A024 11A030 11A052 11A074 11A075 08K001 08K003 08K053 08K077 08M002 08N007 08N029 08N030 08N034 08N069 08N070 09A001 09A063 98026 98069 98071 09C046 90025 90032 90070 09E030 09F022 09F026 09G010 09H005 09H037 09J005 09J042 09J043 09J044 09J045 09J089 09K020 09K050 09M001 09M041 09N032 09N041 10A017 10A022 10A046 108014 108024 10C076 10C100 10C102 100025 100029 10E002 10E007 10E045 10E055 10G001 10G003 10G004 10H024 10H058 10H059 10H072 10J021 10J024 10J027 10J072 10K046 10K048 10K063 10K064 10M034 10M057 10N023 10N077 11A023 11A031 11A054 08K067 08M003 09A006 98078 90026 90085 09E052 09H001 09J071 09K053 09M003 09M077 108025 10C005 10C080 10C101 100059 10E053 10H023 10H106 10J030 10J045 10J069 10K066 10M086 10N027 11A025  Expiration Dates: 06/30/13, 12/31/13, 12/31/14, 06/30/14, 12/31/14, 06/30/15,12/31/15, 06/30/15
  • 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: SV Elastomeric Infusion Device. || 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