BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx… recallZ-1317-2015 · Becton Dickinson & Company · initiated Feb 19, 2015
Class II Terminated All recalls posted in March 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
FDA root cause category: Process control
What the company is doing
Becton Dickinson sent an Urgent Voluntary Product Recall Letter/Recall Response Card/Packing Instructions, dated 2/19/15, to their affected customers via UPS next day mail. The letters identified the affected device and explained the reason for the recall. Customers were to review their inventory for the specific catalog and lot numbers provided and quarantine the affected product. The Recall Response Card form should be completed and faxed back to BD at 1-866-514-2113 or e-mail [email protected]. All affected product should be returned with the completed Recall Response Card following the steps on the enclosed packing instruction. Upon receipt of the returned product, BD will send customers replacement product. If customers have questions or require assistance, they should contact 1-866-800-2917.
Recall details
- Recall number
- Z-1317-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 19, 2015
- Posted by the FDA
- Mar 25, 2015
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 315,800 units
- Product code
- FPA
- FDA submissions
- K013621
- Distribution
- Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.
Product description
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.
Code information (models, lots, serial numbers)
Lot #'s 4128925 and 4128926
Other devices under the same FDA submission
5 devices cleared under K013621 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BD Q-Syte 385100Becton, Dickinson And Company · Set, administration, intravascular1 death971 reports
- BD Q-Syte 385102Becton, Dickinson And Company · Set, administration, intravascular269 reports
- BD Q-Syte 385101Becton, Dickinson And Company · Set, administration, intravascular27 reports
- BD Q-Syte 385108Becton, Dickinson And Company · Set, administration, intravascular18 reports
- Q-Syte 385103Becton, Dickinson And Company · Set, administration, intravascular4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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