EndoVive 20Fr Push Standard PEG Kit w/ENFit recall
EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who…
Why was EndoVive 20Fr Push Standard PEG Kit w/ENFit recalled?
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
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?
GTIN: 08714729880493 Lot Numbers: 32162452, 32370861, 32714500
- Product
- EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 572 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Japan.
- Recall date
- April 17, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)