Class II — Applied Medical Resources Corp
| Recalling firm | APPLIED MEDICAL RESOURCES |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 2,016 units |
| Distribution | Worldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland |
| Initiated | 2019-01-28 |
| Classified | 2019-07-11 |
| Terminated | 2020-06-12 |
| Recall number | Z-1959-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Applied Medical Resources Corp (Z-1959-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82986/
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