Recall Z-1317-2015 ยท FPA Set, Administration, Intravascular
Becton Dickinson & Company
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.
| Date | Mar 25, 2015 (initiated Feb 19, 2015) |
| Status | Terminated |
| Reason | Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum. |
| 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 bd7043@stericycle.com. All affected product should be returned with the completed Recall Response Card following |
| Quantity | 315,800 units |
| Distribution | Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 Becton Dickinson Infusion Therapy Systems, Inc., Apr 16, 2002 |