Events

Recall of Device Recall A2376 Extra Supplies Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heritage Labs International 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
    64848
  • Event Risk Class
    Class 2
  • Event Number
    Z-1131-2013
  • Event Initiated Date
    2013-02-06
  • Event Date Posted
    2013-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117176
  • 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
    The product has a lithium heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
  • Action
    The recalling firm contacted 25 of their 26 customers by phone on February 5, 2013, to notify them of the recall and sent a follow up memo on February 6, 2013, During the call, the firm reminded their customers how many recalled kits they recieved and instructed them to go through the kits and pull the recalled lots. The recalled kits are to be returned to the recalling firm and the firm sent a follow-up memo on February 6, 2013, with the shipping label their customers to place on the returning kit shipping box. This memo was sent to the customers by overnight Fed-ex mail and the ship label for the returned product was an overnight UPS label. On February 7, 2013, the final customer was notified by phone and instructed to return the recalled kits. For further questions please call (913) 764-1045.

Device

Device Recall A2376 Extra Supplies Kit
  • Model / Serial
    Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.
  • Product Description
    Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. || The kit is used by health care providers when treating patients.
  • Manufacturer
    Heritage Labs International LLC

Manufacturer

Heritage Labs International LLC
  • Manufacturer Address
    Heritage Labs International LLC, 560 N Rogers Rd, Olathe KS 66062-1211
  • Source
    USFDA