Device product
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK
Z-1639-2021
Product summary
- Event
- Event 87696
- Status
- Terminated
- Classification
- Class II
- Quantity
- 330 units
- Official record key
device-enforcement:Z-1639-2021
Official wording
Reason: Products labeled as sterile were distributed, but may not have been sterilized.
Code information: LOT: 2001201, 2003859, 20051288, 20061419
Distribution pattern: US Nationwide distribution in the states MS and KY.
Derived failure modes
-
Unknown
Products labeled as sterile were distributed, but may not have been sterilized.