Device recall

Z-1945-2019: ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and…

FDA device recall · Class II · Bio-Detek, Inc.

Key facts

Recall number (Z-number) Z-1945-2019
Recall event 83040
Product ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Product code DTE
Recalling firm Bio-Detek, Inc.
Recall class Class II
Status Terminated
Termination date Jun 1, 2020
510(k) numbers K960676
FEI number 1218058

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)