CooperSurgical Recalls Advanced Endosee Cannulas Due to Unsealed Pouches
CooperSurgical is recalling 460 boxes of Advanced Endosee Cannulas because some sterile pouches may be unsealed, potentially compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential breach of sterility in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses have been reported in the source text.
Plain-English summary
CooperSurgical, Inc. is recalling 460 boxes of the Advanced Endosee System Cannula (Product Code: ESPX5). The recall involves two specific lots: Lot 268748 (expiration date 04/27/2020) and Lot 269360 (expiration date 07/30/2020). The product is a sterile, single-use cannula used for live visualization and diagnostic imaging.
The recall was initiated due to a potential for unsealed pouches in the affected lots. An unsealed pouch could compromise the sterile barrier of the device, which is a critical safety requirement for single-use medical instruments.
The affected units were distributed to 38 states and the District of Columbia in the United States. No international distribution is reported. Healthcare facilities and distributors should stop using the affected lots and contact CooperSurgical for instructions on return or replacement.
The recalled product
- Product
- 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…
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 460
Distribution
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