The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1131-2013·Announced 2013-04-24

Heritage Labs Path Study Extra Supplies Kit Recalled for Contamination

Heritage Labs is recalling 25 Path Study Extra Supplies Kits because they contain blood collection tubes with a Lithium Heparin contaminant that could cause erroneous lab results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard (erroneous lab results) has not yet been reported as causing injury, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Heritage Labs International LLC is recalling 25 units of the Path Study Extra Supplies Kit, Product # A 2376. The kit contains three zippered plastic bags holding support supplies for health care providers, including blood collection tubes and needles. The recall involves specific lots: A2376-12307 (exp 2/28/2013) and A2376-12272 (exp 4/30/2013). The affected kits were distributed nationwide, including in Alabama, California, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, North Carolina, New York, Oklahoma, and Virginia.

The recall is being issued because the kits contain BD blue top citrate tubes that have a Lithium Heparin contaminant. This contaminant could adversely affect coagulation results, potentially causing erroneous laboratory results for patients. The tubes were manufactured by BD in Franklin Lakes, New Jersey.

Health care providers who have these kits should stop using the affected blood collection tubes and contact Heritage Labs International LLC for further instructions. Consumers are not directly affected by this recall, as the product is intended for use by health care providers.

The recalled product

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…
Manufacturer
Heritage Labs International LLC
Category
Medical Device — Blood Collection Tubes
Hazard
Affected units
25

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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