Device recall

Z-0120-2019: Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This…

FDA device recall · Class II · A M Systems Inc

Key facts

Recall number (Z-number) Z-0120-2019
Recall event 81076
Product Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.
Product code BYX
Recalling firm A M Systems Inc
Recall class Class II
Status Terminated
Termination date May 13, 2021
FEI number 3020614

At a glance

  • None 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

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