CODMAN BACTISEAL EVD Catheter Set - Indicated for recall: Sterility Concern
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices…
Why was CODMAN BACTISEAL EVD Catheter Set - Indicated for recalled?
Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.
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?
UDI-DI: 10381780515593 Lot numbers: 7320001, 7320004, 720005, 7322926, 322927
- Product
- CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 135 units
- Distribution
- Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey
- Recall date
- June 19, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)