PlainRecalls
FDA Devices Moderate Class II Terminated

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 o

Reported: January 22, 2020 Initiated: December 13, 2019 #Z-0798-2020

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).

Details

Recalling Firm
CooperSurgical, Inc.
Units Affected
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
Location
Trumbull, CT

Frequently Asked Questions

What product 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.. Recalled by CooperSurgical, Inc.. Units affected: 460.
Why was this product recalled? ▼
Potential for unsealed pouches in two (2) lots of the Endosee Advance Cannula (P/N: ESPX5).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2020. Severity: Moderate. Recall number: Z-0798-2020.

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