Recall Z-1959-2019 ยท GCJ Laparoscope, General & Plastic Surgery
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 instrum
| Date | Jan 28, 2019 |
| 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. |
| 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 distributo |
| Quantity | 2,016 units |
| Distribution | Worldwide Distribution - US Nationwide Distribution: OUS: Japan, Australia, New Zealand, Spain, Italy, Great Britain, Germany, France, and Finland |
| FDA record | Open on fda.gov |