Recall Z-1584-2018 ยท DRC Trocar
CooperSurgical, Inc.
5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count); Model Number 900-840 Product Usage: The Apple-Hunt Secondary Cannulas are indicated for use in laparoscopic surgical procedures to provide a pathway for the introduction of endoscopic surgical instruments and allow for maintenance of pneumoperitoneum. For uninhibited laparoscopic access, the Apple-Hunt Cannula/Tro
| Date | Mar 12, 2018 |
| Status | Terminated |
| Reason | Products have been packaged with the wrong Trocar length type. |
| Root cause | Under Investigation by firm |
| Action | On March 26, 2018 CopperSurgical Inc. mailed a Medical Device Recall Notification to affected customers. Customers were instructed to discontinue the use of the affected lot number 223333 and complete an Acknowledgement and Receipt Form to schedule refund or exchanges. If customers supplied products to any other facility, they have been asked to provide the recipients a copy of the notification letter. Customers with questions may contact CopperSurgical at recall@coopersurgical.com. |
| Quantity | 520 products |
| Distribution | Worldwide Distribution - US Nationwide in the states of FL, GA, IN, NJ, and countries of Canada, Austria, Chile, Italy, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911462 | SURGICAL TROCAR Applied Medical, Apr 22, 1991 |