Drug recall
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton…
FDA recall event 70593 · Class II · Becton Dickinson & Company
Key facts
| Event ID | 70593 |
|---|---|
| Recall numbers | Z-1317-2015 |
| Recalling firm | Becton Dickinson & Company |
| Product type | Devices |
| Products | BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular administration set… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum. |
| Initiation date | Feb 19, 2015 |
| Report date | Apr 1, 2015 |
| Termination date | May 25, 2017 |
| City | Franklin Lakes |
| State | NJ |
| Country | United States |
| FEI number | 2243072 |
At a glance
- 1–9 Products in this recall
- 10–99 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: