Device recall

Z-2221-2018: BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number…

FDA device recall · Class II · Angiodynamics Inc. (Navilyst Medical Inc.)

Key facts

Recall number (Z-number) Z-2221-2018
Recall event 80169
Product BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019
Product code LJS
Recalling firm Angiodynamics Inc. (Navilyst Medical Inc.)
Recall class Class II
Status Terminated
Termination date May 13, 2020
510(k) numbers K163452
FEI number 3017892510

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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

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