FDA recall Z-0120-2019

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.

Reason for recall

Some of the Disposable Smooth Interior Tubing may pull apart when stretched.

Distribution

US Distribution to states of: OH, PA, and NC.

Key facts

Status

Terminated

Initiation date

2018-08-10

Report date

2018-10-24

Termination date

2021-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sequim, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0120-2019