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.
FDA Recall Z-1964-2020 · Posted None
Recalling FirmBard Peripheral Vascular Inc
Recall StatusOpen, Classified
Product CodeLJT
Date Initiated2020-01-15
Product Quantity200 units
Reason for Recall
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Firm Action
The recalling firm issued letters dated 1/15/2020 via FedEx with proof of delivery notification. The devices were to be returned.
Root Cause
Employee error
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.