Class II — Becton Dickinson & Company
| Recalling firm | Becton Dickinson and Company |
|---|---|
| Registered facility | View this company's 36 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum. |
| Product | 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 that permits injection, gravity flow or withdrawal of fluids. |
| Quantity | 315,800 units |
| Distribution | Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA. |
| Initiated | 2015-02-19 |
| Classified | 2015-03-25 |
| Terminated | 2017-05-25 |
| Recall number | Z-1317-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Becton Dickinson & Company (Z-1317-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70593/
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