EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM recall
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Why was EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM recalled?
Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UPN M00509500, GTIN (UDI-DI) 08714729902713, Lot 31073152; UPN M00509510, GTIN (UDI-DI) 08714729902720, Lots 31221751, 31761882, 32409573.
- Product
- EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 0 US; 74 OUS
- Distribution
- International distribution to the country of Japan only.
- Recall date
- February 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)