Medical device recalls Moderate risk

Becton Dickinson & Company recalls BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infu…

Recall date
February 19, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1317-2015
FDA classification
Class II
Brand / firm
Becton Dickinson & Company
Sold / distributed
Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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