Device recall

Z-2468-2021: BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access…

FDA device recall · Class II · CAREFUSION

Key facts

Recall number (Z-number) Z-2468-2021
Recall event 88203
Product BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006
Product code FPA
Recalling firm CAREFUSION
Recall class Class II
Status Open, Classified
510(k) numbers K970485
FEI number 3012410077

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 Products in the same recall event
  • 1,000+ 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)