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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