Recall Z-1317-2015— Becton Dickinson & Company

Name: FDA recall Z-1317-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-19

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2015-02-19, terminated 2017-05-25. It names one FDA 510(k) clearance: K013621. 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..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2015-02-19
Terminated: 2017-05-25
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K013621 — BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100Becton Dickinson Infusion Therapy Systems, Inc.·cleared 2002-04-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.

Data sourced from openFDA. This site is unofficial and independent of the FDA.