Device recall

Z-0115-2024: HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004

FDA device recall · Class II · Access Vascular, Inc

Key facts

Recall number (Z-number) Z-0115-2024
Recall event 93043
Product HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Product code LJS
Recalling firm Access Vascular, Inc
Recall class Class II
Status Open, Classified
510(k) numbers K213550
FEI number 3021570645

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)