FDA Recall
Open, Classified
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.
Recall: Z-1964-2020
·
Initiated January 15, 2020
Recall
- Recall Number
- Z-1964-2020
- Event Number
- 85476
- Firm
- Bard Peripheral Vascular Inc
- FEI Number
- 2020394
- Product Code
- LJT
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- January 15, 2020
- Address
- 1625 W 3rd St, Bldg 1, Tempe, AZ, 85281-2438
Description
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.
Reason
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Action
The recalling firm issued letters dated 1/15/2020 via FedEx with proof of delivery notification. The devices were to be returned.
Distribution
US Nationwide distribution including in the states of AZ, CA, MA, MD, NJ, NY, and TX. There was no foreign/government/military distribution.
Quantity
200 units