Events

Recall of Device Recall ABGHM1 Hummi Micro Draw Blood Transfer Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hummingbird Med.

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
    72350
  • Event Risk Class
    Class 1
  • Event Number
    Z-1636-2016
  • Event Initiated Date
    2015-10-01
  • Event Date Posted
    2016-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140711
  • 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
    System, blood collection, vacuum-assisted, manual - Product Code KST
  • Reason
    Hummingbird med devices, inc. is recalling abg-hm-1 hummi micro draw blood transfer because the connection between the "hummi" y connector and the yellow cannula hub may not be sufficiently secure enough and could separate while in use.
  • Action
    On 10/01/15 the firm sent out customer notification letters. The letter states for the following actions to be taken: 1. Customers using the Hummi Micro Draw device are recommended not to use the identified lot. 2. A local distributor/sales representative will be contacting customers to arrange a return of the identified lot for credit and arrangement of replacement. 3. Replacement product should be available within 10 days of 10/30/15. 4. During the period of product unavailability customers might want to choose to temporarily to return their previous method for blood drawing. The firm requests a Reply Form be completed and returned via fax at 949-583-2775 or email to JorgeHaider@hummingbirdmed.com. On 11/19/2015 the firm sent out a second notification letter involving additional recall lots. The firm provided the same instructions to customers as their previous notification; however stated replacement product should be available by mid December 2015.

Device

Device Recall ABGHM1 Hummi Micro Draw Blood Transfer Device
  • Model / Serial
    Lot 15180, 15286, 15287, 15300, 15305
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA, KY, MD, GA, and IL.
  • Product Description
    ABG-HM-1 Hummi Micro Draw Blood Transfer Device || Product Usage: || It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
  • Manufacturer
    Hummingbird Med

Manufacturer

Hummingbird Med
  • Manufacturer Address
    Hummingbird Med, 20371 Lake Forest Dr Ste A6, Lake Forest CA 92630-8106
  • Source
    USFDA