Z-1964-2020 Class II Ongoing
FDA device recall Z-1964-2020 was initiated by Bard Peripheral Vascular Inc on January 15, 2020 and is designated Class II. Reason for recall: The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling. The recall status is ongoing. Affected quantity: 200 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- January 15, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 units
Product 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 for Recall
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Distribution Pattern
US Nationwide distribution including in the states of AZ, CA, MA, MD, NJ, NY, and TX. There was no foreign/government/military distribution.
Code Information
Lot #RECX3530, Exp. date 4/30/2020, UDI (01)00801741110771(17)200430(10)RECX3530.