Device product
Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
Z-1780-2019
Product summary
- Firm
- Cook Inc.
- Event
- Event 82910
- Status
- Terminated
- Classification
- Class II
- Quantity
- 97
- Official record key
device-enforcement:Z-1780-2019
Official wording
Reason: The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.
Code information: lot 8373482
Distribution pattern: No distribution in the US. Products were distributed to the following foreign countries: China.
Derived failure modes
-
Unknown
The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.