Device product
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
Z-0899-2018
Product summary
- Event
- Event 79199
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,000 units
- Official record key
device-enforcement:Z-0899-2018
Official wording
Reason: Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.
Code information: Lot No P1607442.
Distribution pattern: US Distribution to Puerto Rico.
Derived failure modes
-
Labeling or packaging
missing labels