Z-1131-2013Class II

Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which...

Name: Z-1131-2013 Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which...
Creator: Heritage Labs International LLC
Published: 2013-02-06
License: https://open.fda.gov/license/

Heritage Labs International LLC / initiated 2013-02-06 / Terminated / root cause: manufacturing process

FDA source

Heritage Labs International LLC began a recall of 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... on 2013-02-06. FDA classified it as Class II and gives the reason as "The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1131-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-06
Posted: 2013-04-18
Terminated: 2013-11-25
Recalling firm: Heritage Labs International LLC
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.
Product code: KST System, Blood Collection, Vacuum-Assisted, Manual
Reason for recall: The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1131-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1131-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-18

Product code KST

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)