Recall Z-1584-2018— CooperSurgical, Inc.

Name: FDA recall Z-1584-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-12

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2018-03-12, terminated 2019-05-08. It names one FDA 510(k) clearance: K911462. 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.. Reason: Products have been packaged with the wrong Trocar length type..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-12
Terminated: 2019-05-08
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K911462 — SURGICAL TROCARApplied Medical·cleared 1991-04-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.