Recall Z-2533-2017 ยท GCJ Laparoscope, General & Plastic Surgery
Applied Medical Resources Corp
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
| Date | Jun 14, 2017 (initiated May 4, 2017) |
| Status | Terminated |
| Reason | Due to possibility of insufficient sterilization. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Recall letter dated 5/4/17 was sent to customers to inform them that Applied Medical is conducting a voluntary recall of specific lots of Kii trocar models, CTB14 Kii 5x55mm Shielded Bladed Z-Thread Dual Pack and CTB23 Kii 5x55mm Low Profile Bladed Z-Thread Dual Pack, due to the possibility of insufficient sterilization. Customers are instructed to complete the attached recall notification confirmation form to acknowledge the recall and indicate if their facility is returning or already used the lots on recall. Customers are instructed to return the Recall Notificati |
| Quantity | 7,939 units total (870 units in US) |
| Distribution | US and worldwide: Australia, Finland, France, United Kingdom |
| FDA record | Open on fda.gov |