Device product
smiths medical portex Loss of Resistance Device, REF 100/398/000
Z-0152-2022
Product summary
- Event
- Event 88741
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3420 devices
- Official record key
device-enforcement:Z-0152-2022
Official wording
Reason: The labeling was missing information on sterilization and prohibition of reuse.
Code information: Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003
Distribution pattern: Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates
Derived failure modes
-
Labeling or packaging
labeling was missing