Z-0798-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2020
- Initiation Date
- December 13, 2019
- Termination Date
- May 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 460
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).
Distribution Pattern
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