Exact FDA event identifier

Event 64848

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: February 06, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Heritage Labs International LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1131-2013

Recall number: Z-1131-2013
Initiated: February 06, 2013
Classification: Class II
Status: Terminated
Recalling firm: Heritage Labs International LLC
Quantity: 25 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013

Distribution pattern

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