Kii Fios First Entry recalled over sterility concerns

Recall date

January 28, 2019

Source

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

Official notice title

Applied Medical Resources Corp recalls Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medica…

Recall number

Z-1959-2019

FDA classification

Class II

Brand / firm

Applied Medical Resources Corp

Sold / distributed

Worldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland

Why it was recalled

The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.

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

What was recalled

Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.