Z-1584-2018 Class II Terminated
FDA device recall Z-1584-2018 was initiated by CooperSurgical, Inc. on Mar 12, 2018 and is designated Class II. Reason for recall: Products have been packaged with the wrong Trocar length type. The recall status is terminated (terminated May 8, 2019). Affected quantity: 520 products.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- Mar 12, 2018
- Termination Date
- May 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 520 products
Product Description
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.
Reason for Recall
Products have been packaged with the wrong Trocar length type.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of FL, GA, IN, NJ, and countries of Canada, Austria, Chile, Italy, Singapore
Code Information
Lot number 223333
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1584-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026