Device recall

Z-0090-2023: ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units…

FDA device recall · Class II · B. Braun Medical, Inc.

Key facts

Recall number (Z-number) Z-0090-2023
Recall event 90850
Product ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
Product code FPA
Recalling firm B. Braun Medical, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K955585
FEI number 2523676

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 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)