FDAClass IIApril 1, 2015

BD Q-Syte Luer Access Split Septum recall

BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An…

Why was BD Q-Syte Luer Access Split Septum recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #'s 4128925 and 4128926

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…
Recalling firm
Becton Dickinson & Company
Quantity
315,800 units
Distribution
Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.
Recall date
April 1, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls