ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced...
FDA Recall #Z-0798-2020 — Class II — December 13, 2019
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).
Recalling Firm
CooperSurgical, Inc. — Trumbull, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
460
Distribution
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
Code Information
Lot 268748 - Expiration date: 04/27/2020 Lot 269360 - Expiration date: 07/30/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated