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

FDA device recall Z-1131-2013 · posted 2013-04-18 · Terminated

Recall details

Recalling firm

Heritage Labs International LLC

Reason for recall

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

Action taken

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

Status

Terminated

Product code

KST

Quantity affected

25 kits

Distribution

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

Date initiated

2013-02-06

Date posted

2013-04-18

Date terminated

2013-11-25

Location

Olathe, KS