Device recall

Z-0960-2025: VDR4 Phasitron Breathing Circuit Models that contain the venturi component…

FDA device recall · Class I · Percussionaire Corporation

Key facts

Recall number (Z-number) Z-0960-2025
Recall event 95979
Product VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification…
Product code CBK
Recalling firm Percussionaire Corporation
Recall class Class I
Status Open, Classified
510(k) numbers K905235
FEI number 1000524541

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)