FDA Device recall Z-1317-2015
BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems…
- FDA Device
- Class II
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class II recall of BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems… by Becton Dickinson And, citing becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1317-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-19 |
| Published | 2015-04-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Becton Dickinson And |
| Distribution | CA, CT, FL, IL, MA, ND, NY, OH, PA |
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.
Reason
Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
Identifiers
| code_info | Lot #'s 4128925 and 4128926 |
|---|
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-1317-2015%22
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