CooperSurgical, Inc. recalls ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperS…

Recall date

December 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0798-2020

FDA classification

Class II

Brand / firm

CooperSurgical, Inc.

Sold / distributed

US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, WV, & WY. OUS: None

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.