Drug recall
Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold…
FDA recall event 64848 · Class II · Heritage Labs International LLC
Key facts
| Event ID | 64848 |
|---|---|
| Recall numbers | Z-1131-2013 |
| Recalling firm | Heritage Labs International LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results. |
| Initiation date | Feb 6, 2013 |
| Report date | Apr 24, 2013 |
| Termination date | Nov 25, 2013 |
| City | Olathe |
| State | KS |
| Country | United States |
| FEI number | 1000118383 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: