Device recall

Z-1013-2022: WAVES WCM Kidney Cassette Module

FDA device recall · Class II · Waters Medical Systems LLC

Key facts

Recall number (Z-number) Z-1013-2022
Recall event 89841
Product WAVES WCM Kidney Cassette Module
Product code KDN
Recalling firm Waters Medical Systems LLC
Recall class Class II
Status Terminated
Termination date Aug 16, 2024
510(k) numbers K111521
FEI number 2123774

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)