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.
What this means for you
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 dr
- Manufacturer
- Heritage Labs International LLC
- 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
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