Z-1317-2015Class II

BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton...

Name: Z-1317-2015 BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton...
Creator: Becton Dickinson & Company
Published: 2015-02-19
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2015-02-19 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of 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... on 2015-02-19. FDA classified it as Class II and gives the reason as "Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1317-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-19
Posted: 2015-03-25
Terminated: 2017-05-25
Recalling firm: Becton Dickinson & Co
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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 315,800 units
Distribution: Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.
Product codes and lots: Lot #'s 4128925 and 4128926

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1317-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1317-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-25

Product code FPA

K013621Class IIBd Saf-T Prn Luer Activated Valve, Model 385100Becton Dickinson Infusion Therapy Systems, Inc. / cleared 2002-04-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)