Device recall

Z-0012-2020: Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes…

FDA device recall · Class II · Inter-Med Llc

Key facts

Recall number (Z-number) Z-0012-2020
Recall event 83435
Product Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Product code KJJ
Recalling firm Inter-Med Llc
Recall class Class II
Status Terminated
Termination date Aug 10, 2021
510(k) numbers K082470
FEI number 3000209941

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)