Heritage Labs Path Study Extra Supplies Kit — Class II medical device recall Z-1131-2013
Terminated recall by Heritage Labs International LLC, reported 2013-04-24, distributed nationwide. The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially cau
| Recall number | Z-1131-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heritage Labs International LLC, Olathe, KS, United States |
| Recall initiated | 2013-02-06 |
| Classified | 2013-04-18 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-11-25 |
| Distributed | Nationwide (US) |
| Quantity | 25 kits |
| Lot numbers | A2376-12272, A2376-12307 |
| Expiration dates | 2013-02-28, 2013-04-30 |
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 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.
Reason for recall
The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1131-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.