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U.S. Department of Health and Human Services

Class 2 Device Recall A2376 Extra Supplies Kit

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 Class 2 Recall
A2376 Extra Supplies Kit
see related information
Date Posted April 18, 2013
Recall Status1 Terminated on November 25, 2013
Recall Number Z-1131-2013
Recall Event ID 64848
Product Classification System, Blood Collection, Vacuum-Assisted, Manual - Product Code KST
Product 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.
Code Information Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013
Recalling Firm/
Manufacturer
Heritage Labs International LLC
560 N Rogers Rd
Olathe, Kansas 66062-1211
Manufacturer Reason
for Recall
The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
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.
Quantity in Commerce 25 kits
Distribution Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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