FDA Device recall Z-1131-2013
Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health…
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health… by Heritage Labs International, citing the product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1131-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-06 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Heritage Labs International |
| Distribution | US |
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
The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
Identifiers
| code_info | Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1131-2013%22
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