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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 Device Recall A2376 Extra Supplies Kitsee related information
Date Initiated by FirmFebruary 06, 2013
Date PostedApril 18, 2013
Recall Status1 Terminated 3 on November 25, 2013
Recall NumberZ-1131-2013
Recall Event ID 64848
Product Classification System, blood collection, vacuum-assisted, manual - Product Code KST
ProductHeritage 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
FEI Number 1000118383
Recalling Firm/
Manufacturer		 Heritage Labs International LLC
560 N Rogers Rd
Olathe KS 66062-1211
For Additional Information Contact
913-764-1045
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		Material/Component Contamination
ActionThe 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 Commerce25 kits
DistributionNationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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