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.
This recall has been terminated (originally issued January 28, 2019).
- Recall Initiated
- January 28, 2019
- Terminated
- June 12, 2020
- Recall Number
- Z-1959-2019
- Quantity
- 2,016 units
- Firm Location
- Margarita, CA
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot: 1330981, Exp: July 15, 2021 UDI: 0 0607915 12312 3
Root Cause
Packaging
Action Taken
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.