Recall Z-1210-2019 ยท FPA Set, Administration, Intravascular
Becton Dickinson & Company
SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
| Date | Jun 26, 2019 (initiated Feb 28, 2019) |
| Status | Terminated |
| Reason | Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates. |
| Root cause | Process control |
| Action | BD distributors provided a hard copy of the recall letter on February 28, 2019 via FedEx and may also be contacted via e-mail (when available). Distributors are requested to identify their customers and provide BD a customer list so that BD can undertake further communication to the users. BD will distribute the recall communication to the distributor customers via FedEx upon receiving the customer information from the distributors. A copy of the BD product recall customer letter was provided to distributors, in the case they opt to contact their customers directly. BD is requesting that cust |
| Quantity | 2900 Sets |
| Distribution | US Nationwide Distribution in the states of AR, NH, NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811885 | 30-30-2 700 SYRINGE EXTENSION SET Y, Aug 25, 1981 |