Drug recall
4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical…
FDA recall event 70369 · Class II · Churchill Medical Systems, Inc.
Key facts
| Event ID | 70369 |
|---|---|
| Recall numbers | Z-1467-2015, Z-1468-2015, Z-1469-2015, Z-1470-2015, Z-1471-2015, Z-1472-2015, Z-1473-2015, Z-1474-2015, Z-1475-2015, Z-1476-2015, Z-1477-2015, Z-1478-2015 |
| Recalling firm | Churchill Medical Systems, Inc. |
| Product type | Devices |
| Products | 4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids, 4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids, 4" Microbore Trifurcated Ext set, Product Code: BN-308 Accessory device used to administer medical fluids, 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV Accessory device used to administer medical fluids, 6" Trifurcated Extension Set, Product Code: AMS-375-1 Accessory device used to administer medical fluids and 6 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for leaking caused by insufficient bond between needleless device and female luer. |
| Initiation date | Jan 15, 2015 |
| Report date | Apr 29, 2015 |
| Termination date | Feb 25, 2016 |
| City | Dover |
| State | NH |
| Country | United States |
| FEI number | 1000120555 |
At a glance
- 10–99 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: