FDA Device recall Z-1959-2019
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
- FDA Device
- Class II
- terminated
- Published 2019-07-17
On 2019-07-17 the FDA classified a Class II recall of 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 by Applied Medical Resources, citing the product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1959-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-28 |
| Published | 2019-07-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Applied Medical Resources |
| Distribution | US |
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
The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.
Identifiers
| code_info | Lot: 1330981, Exp: July 15, 2021 UDI: 0 0607915 12312 3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1959-2019%22
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