Events

Recall of Device Recall SmartBlock PainPump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hsmg, Inc. D/b/a Smartinfuser Usa.

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
    57776
  • Event Risk Class
    Class 2
  • Event Number
    Z-1981-2011
  • Event Initiated Date
    2010-03-17
  • Event Date Posted
    2011-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97377
  • 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
    Elastomeric Infusion Pump - Product Code MEB
  • Reason
    Elastomeric tube in product's compression unit has the potential to burst following filling.
  • Action
    Firm notified consignees by e-mail and telephone on 3/17/2010. The correspondence identified the affected product and lot numbers; and asked that customers specify which parts, lot numbers and in what quantities they still had in their possession.

Device

Device Recall SmartBlock PainPump
  • Model / Serial
    Lot numbers: 1051003, 11051004, 11051005, 1052004, 10052005, 11052006, 1053002, and 1054002.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S.
  • Manufacturer
    Hsmg, Inc. D/b/a Smartinfuser Usa

Manufacturer

Hsmg, Inc. D/b/a Smartinfuser Usa
  • Manufacturer Address
    Hsmg, Inc. D/b/a Smartinfuser Usa, 8588 Katy Fwy Ste 348, Houston TX 77024-1822
  • Source
    USFDA