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Terminated

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.

FDA Recall Z-1131-2013 · Posted 2013-04-18

Recall StatusTerminated
Product CodeKST
Date Initiated2013-02-06
Date Terminated2013-11-25
Product Quantity25 kits

Reason for Recall

The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.

Firm 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.

Root Cause

Material/Component Contamination

Distribution Pattern

Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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