Recall Z-0798-2020— CooperSurgical, Inc.

Name: FDA recall Z-0798-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-13

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2019-12-13, terminated 2021-05-11. It names one FDA 510(k) clearance: K190639. Product: ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for live visualization. The camera can also capture video and images of the diagnostic area for later diagnostic analysis. The Advanced Endosee Cannulas (P/N: ESPX5) are sold in boxes of 5 units/box. Quantities presented are by box.. Reason: Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5)..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-13
Terminated: 2021-05-11
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K190639 — Endosee SystemCooperSurgical, Inc.·cleared 2019-05-15

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

ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for live visualization. The camera can also capture video and images of the diagnostic area for later diagnostic analysis. The Advanced Endosee Cannulas (P/N: ESPX5) are sold in boxes of 5 units/box. Quantities presented are by box.

Reason for recall

Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).

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