BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infus
FDA device recall Z-1317-2015 · posted 2015-03-25 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 315,800 units
- Distribution
- Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.
- Date initiated
- 2015-02-19
- Date posted
- 2015-03-25
- Date terminated
- 2017-05-25
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 (K013621) | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-04-16 |