Events

Recall of Device Recall GOPump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Symbios Medical Products, LLC.

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
    65192
  • Event Risk Class
    Class 1
  • Event Number
    Z-1452-2013
  • Event Initiated Date
    2013-05-10
  • Event Date Posted
    2013-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118194
  • 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
    Symbios medical products, indianapolis, indiana, is performing a voluntary recall of all gopumps found in the gopump rapid recovery system kits and all goblock kits manufactured with flow control components assembled prior to july 2012. the recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 ml reservoir, 2 ml/hr gopump (pn510031), and the.
  • Action
    Symbios sent UrgentMedical Device Recall notices to all consignees beginning May 10, 2013. A second corrected/amended notice was sent on May 14, 2013 to consignees and a National Press release was issued. May 30,2013, a third amended Urgent Recall Notice was sent to all consignees correcting the pump description and lot number range table on page 5 of the notice. The notices and press release provided identification of the recalled devices including devices in the previous February 2013 recall, described possible adverse events, and included directions to to quarantine product in a secure location, in preparation for return. Consignees were asked to call 317 225-4447 ext. 25, 8:00 a.m to 4:00 p.m. EDT to receive a Returned Goods Authorization Number prior to returning product. Consignees were asked to complete and return the Attached Verification Form. Question and Concerns should be addressed to 317-225-4447 ext 25.

Device

Device Recall GOPump
  • Model / Serial
    Pump 510031, Lot 11-l 00106 to Lot 12-101133  Kit 510042, lots 11-100251 to 13-100128 Kit 510042-BP , lot 12-101300 Kit 510110, lot 11-100664 Kit 510110-BP, Lots 11-100838 to 12-101560 Kit 510350, Lots 11-100353 to 12-100233  Kit 510350-BP, Lots12-100429 to 13-100047  Kit 510556-BP Lots 11-100779 to 12-101552
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution.
  • Product Description
    Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous || Delivery Time : App. 72 hrs when filled to capacity || Sterile EO... found in the following GoPump Kits: || GoPump Kit 510042, w/ Epidural Catheter || GoPump Kit 510042 - BP, w/ Epidural Catheter, BIOPATCH || GoPump Kit 510110, w/2.5" Fenestrated Catheter || GoPumpKit 510110-BP, w/2.5" Fenestrated Catheter,BioPatch || GoPumpKit 510350 w/ Epidural Catheter || GoPump Kit 510350-BP w/ Epidural Catheter, BIOPATCH || GoPumpKit 510556-BP , 2.5 catheter, BIOPATCH || Symbios GOPump Rapid Recovery System is a local pain mangagement system that consits of a small balloon that is inflated with a local anesthetic medication.
  • Manufacturer
    Symbios Medical Products, LLC

Manufacturer

Symbios Medical Products, LLC
  • Manufacturer Address
    Symbios Medical Products, LLC, 7301 Georgetown Rd., Suite 150, Indianapolis IN 46268
  • Source
    USFDA