Device recall

Z-0113-2015: Bionector Needleless connector. Bionector is a multi-purpose catheter accessory…

FDA device recall · Class II · Vygon Corporation

Key facts

Recall number (Z-number) Z-0113-2015
Recall event 69204
Product Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
Product code FOZ
Recalling firm Vygon Corporation
Recall class Class II
Status Terminated
Termination date Mar 30, 2015
510(k) numbers K070705
FEI number 2245270

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)