Signia Tri-staple 2.0 30mm Medium/ Thick Reload recall
SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
Why was Signia Tri-staple 2.0 30mm Medium/ Thick Reload 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?
N6E0033UX N6H0768UX N6H0772UX N6K0521UX N6K0522UX N6K0667UX N6K0668UX N6L0687UX N6M0399UX N7A0018UX N7A0213UX N7A0401UX N7A0837UX N7B0787UX N7C0238X N7C0470X N7E0496X N7E1088X N7F0670X N7H0962X N7J0370X N8A0188X N8B0057X N8B0483X N8B0940X N8D0365X N8D0649X N8E0092X N8E0213X N8E0516X N8E1178X N8F0483X N8F0819X N8F0974X N8J0440X N8L0589Y N8M0529Y N9A0050Y N9A0427Y
- Product
- SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
- 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)