Device recall

Z-0710-2017: BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit…

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

Key facts

Recall number (Z-number) Z-0710-2017
Recall event 75322
Product BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not…
Product code LJS
Recalling firm Angiodynamics Inc. (Navilyst Medical Inc.)
Recall class Class II
Status Terminated
Termination date Jun 15, 2018
510(k) numbers K142616
FEI number 3017892510

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

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