Events

Recall of Device Recall Medical Action Industries, IV Start Bundle Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Action Industries Inc.

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
    53880
  • Event Risk Class
    Class 1
  • Event Number
    Z-1073-2010
  • Event Initiated Date
    2009-11-06
  • Event Date Posted
    2010-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86796
  • 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
    IV Start Bundle Kit - Product Code FPA
  • Reason
    Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
  • Action
    On 11/6/2009 a letter was drafted and sent by email to three (3) Medical Action Industries customers. They were instructed to return the recalled products in inventory to MAI. They further advised, if the product was distributed to notify their customer, inform them of the recall and instruct them to return the affected lots to MAI.

Device

Device Recall Medical Action Industries, IV Start Bundle Kit
  • Model / Serial
    Part number: 69946B, Lot numbers: 62295, 63591, 64197, 65175, 67162, 69906, 72113 and 73617.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution
  • Product Description
    Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.
  • Manufacturer
    Medical Action Industries Inc

Manufacturer

Medical Action Industries Inc
  • Manufacturer Address
    Medical Action Industries Inc, 25 Heywood Rd, Arden NC 28704-9302
  • Manufacturer Parent Company (2017)
    Owens & Minor Inc
  • Source
    USFDA