Medical Device Recall: Non-Sterile Iodine Pouches Mislabeled as Sterile
CooperSurgical is recalling 991 Endosee System Convenience Kits (Model ES-TRAY) because the iodine pouches are non-sterile but labeled as sterile on the peel-away lid labels. The affected devices were distributed nationwide.
What this means for you
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: This FDA Class II recall involves a sterility labeling issue for a medical device used in clinical procedures. No illnesses or injuries have been reported in the source material, making the hazard theoretical rather than confirmed. This aligns with the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CooperSurgical, Inc. is recalling 991 Endosee System Convenience Kit units (Model ES-TRAY) distributed nationwide. The affected lot numbers are 335995, 339340, 339341, 339342, 339343, 339344, 339345, and 343008. These kits contain iodine pouches used in medical procedures.
The iodine pouches in the recalled kits are non-sterile. However, the peel-away lid labels incorrectly identify them as sterile. This mislabeling creates a discrepancy between the actual product contents and what the label represents.
Consumers and healthcare providers should immediately cease use of affected kits. Contact CooperSurgical or your healthcare provider if you have already used one of these kits in a medical procedure to discuss potential exposure to non-sterile material. Affected healthcare facilities should quarantine these products until proper handling instructions are received from the manufacturer.
The recalled product
- Product
- Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- sterility-issue
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Model Number: ES-TRAY. UDI-DI: 60888937027268. Lot Numbers: 335995
- 339340
- 339341
- 339342
- 339343
- 339344
- 339345
- 343008.
Distribution
Distributed nationwide across the United States.
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