Egia 60 Curved TIP ART MED Thick Sulu recall
EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
Why was Egia 60 Curved TIP ART MED Thick Sulu recalled?
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
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?
N8L0311KY N8M0063KY
- Product
- EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
- Recalling firm
- Covidien LLC
- Quantity
- 3,113,280
- Distribution
- Nationwide domestic distribution, worldwide foreign distribution.
- Recall date
- June 26, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)