BD Q-Syte Luer Access Split Septum — Class II medical device recall Z-1317-2015
Terminated recall by Becton Dickinson & Company, reported 2015-04-01, distributed in CA, CT, FL, IL, MA, ND, NY, OH…. Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tea
| Recall number | Z-1317-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2015-02-19 |
| Classified | 2015-03-25 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2017-05-25 |
| Distributed | CA, CT, FL, IL, MA, ND, NY, OH, PA |
| Quantity | 315,800 units |
| Reason classes | packaging |
| Lot numbers | 4128925, 4128926 |
| Model numbers | 385100 |
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 for recall
Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1317-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.