Device product
CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821749
Z-2137-2024
Product summary
- Event
- Event 94622
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 106 units
- Official record key
device-enforcement:Z-2137-2024
Official wording
Reason: Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
Code information: UDI-DI: 10381780518440 Lot numbers: 7314912, 7320010, 7322933
Distribution pattern: 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
Derived failure modes
-
Labeling or packaging
packaging (pouch) leading to a gap or/and weakness of the seal may compromise
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Sterility assurance
sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise