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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
Recalled July 17, 2019 · FDA recall Z-1959-2019 · Applied Medical Resources
Hazard
The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents. · FDA Class II
Units
2,016 units
Sold at
Worldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland
Description
The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.
Product
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.
Manufacturer(s)
Applied Medical Resources Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →