Events

Recall of Device Recall 3M Ranger(TM) Pressure Infusor, Model 145

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 3M Company - Health Care Business.

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
    77399
  • Event Risk Class
    Class 2
  • Event Number
    Z-2632-2017
  • Event Initiated Date
    2017-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155950
  • 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
    Infusor, pressure, for i.V. Bags - Product Code KZD
  • Reason
    It was discovered that one ranger pressure lnfusor model 145, sn: 100873, produced a left chamber pressure that was slightly below the manufacturing specification.
  • Action
    The firm, 3M, sent a letter dated 5/22/2017, to its consignee/customer. The letter described the product, problem and actions to be taken. The consignee was informed that there is no safety issue; however, the firm will be replacing unit. In addition, a representative from 3M will be visiting the facility and exchanging the product for a new one. Please feel free to call (713) 292-4430 or email baprestera@mmm.com if you have any questions.

Device

Device Recall 3M Ranger(TM) Pressure Infusor, Model 145
  • Model / Serial
    Serial Number: 100873
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    U.S. Distribution: TX only
  • Product Description
    3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 || The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Manufacturer Address
    3M Company - Health Care Business, 3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144-0001
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    USFDA