# FDA recall Z-1959-2019

> **Applied Medical Resources Corp** · Class II · device recall initiated 2019-01-28.

## 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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-1959-2019
- **Recalling firm:** Applied Medical Resources Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-28
- **Report date:** 2019-07-17
- **Termination date:** 2020-06-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rancho Santa Margarita, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1959-2019

## Citation

> AI Analytics. FDA recall Z-1959-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1959-2019. Source: US FDA. Licensed CC0.

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