FDA Medical Device Recalls (openFDA)
Applied Medical Resources Corp: 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.
- Recall number
- Z-1959-2019
- Recalling firm
- Applied Medical Resources Corp
- 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.
- Status
- Terminated
- Initiated
- 2019-01-28
- Posted
- not on file
- Terminated
- 2020-06-12
- 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.
- Root cause
- Packaging
- Action
- Each US customer was notified via, "Urgent: Medical Device Recall" letter sent via UPS on January 28, 2019. All international consignees are in the process of being notified. The firm request customers compete the following actions: - Check your inventory for recalled product. - Complete the attached Recall Notification Confirmation Form (Page 2) to acknowledge the recall and indicate if your facility is returning or has already used product from the lot listed above. - If no product is being returned, please indicate on the Recall Notification Confirmation Form - If you are a distributor, please notify any facilities to which you distributed the affected product. Please also complete Page 3 of the Recall Notification Confirmation Form. - Return the Recall Notification Confirmation Form to Applied Medical by emailing it to recall60790124@appliedmedical.com or faxing it to (949) 713-8205. - Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical.
- Quantity
- 2,016 units
- Distribution
- Worldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland
- Lot, serial or model codes
- Lot: 1330981, Exp: July 15, 2021 UDI: 0 0607915 12312 3
- 510(k) numbers
- ["K041795","K083638"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 2027111
- Firm city
- Rancho Santa Margarita
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28