Reported Jan 22, 2020 · Terminated

ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula…

CooperSurgical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350

Is this the product you have?

  • ADVANCED ENDOSEE System CANNULA, Cooper
  • Surgical Product Code/Model NumberESPX5 The Advanced Endosee
  • Cannula (CooperSurgical Product CodeESPX5) 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/NESPX5) are sold in boxes of 5 units/box. Quantities presented are by box
Lot codes and dates
  • Lot 268748 - Expiration date04/27/2020
  • Lot 269360 - Expiration date07/30/2020
Amount recalled
460

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 11, 2021 · Data as of Sep 19, 5:26 PM UTC

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