Device product
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/Trocar provides greater instrument maneuverability while maintaining an airtight seal -with no bulky external valves, fittings, or housings. The ergonomic trocar design is simple to use and features a smooth cannula/trocar transition for easier sleeve insertion and reduced risk of patient injury.
Z-1584-2018
Product summary
- Event
- Event 79825
- Status
- Terminated
- Classification
- Class II
- Quantity
- 520 products
- Official record key
device-enforcement:Z-1584-2018
Official wording
Reason: Products have been packaged with the wrong Trocar length type.
Code information: Lot number 223333
Distribution pattern: Worldwide Distribution - US Nationwide in the states of FL, GA, IN, NJ, and countries of Canada, Austria, Chile, Italy, Singapore
Derived failure modes
-
Unknown
Products have been packaged with the wrong Trocar length type.