Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer recalled over sterility concerns

Recall date

August 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

A M Systems Inc recalls Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 102492…

Recall number

Z-0120-2019

FDA classification

Class II

Brand / firm

A M Systems Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.