—#134096

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.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K013621
Affected lot / code info: Lot #'s 4128925 and 4128926

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.

Root cause (FDA determination)

Process control

Action the firm took

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 bd7043@stericycle.com. 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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.

Timeline

Recall initiated: 2015-02-19
Posted by FDA: 2015-03-25
Terminated: 2017-05-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134096. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.