Recall Z-0536-2018 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Bard Access Systems Inc.
PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.
| Date | Feb 6, 2018 (initiated Dec 28, 2017) |
| Status | Terminated |
| Reason | Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction. |
| Root cause | Labeling design |
| Action | Customers were notified via letter on approximately 12/28/2017. Instructions include a reminder that if additional extension sets are attached to the luers of the catheters, they should be appropriately secured as per hospital recommended securement protocol, to refrain from having unsupported extension sets that could put stress on the luer extension leg junction of the catheter, and to notify customers if the product was further distributed. Also, the notification contained a statement that Bard Access is in the process of updating their Instructions for Use to include a statement regardin |
| Quantity | 53,699 units total |
| Distribution | Distribution US nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162443 | PowerPICC Provena Catheters C.R. Bard, Inc., Oct 25, 2016 |