Recall Z-1964-2020 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Bard Peripheral Vascular Inc
BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media.
| Date | Jan 15, 2020 |
| Status | Open, Classified |
| Reason | The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling. |
| Root cause | Employee error |
| Action | The recalling firm issued letters dated 1/15/2020 via FedEx with proof of delivery notification. The devices were to be returned. |
| Quantity | 200 units |
| Distribution | US Nationwide distribution including in the states of AZ, CA, MA, MD, NJ, NY, and TX. There was no foreign/government/military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122899 | POWERPORT CLEARVUE SLIM IMPLANTABLE PORT C.R. Bard, Inc., Nov 15, 2012 |