Device product
MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
Z-0051-2017
Product summary
- Event
- Event 75213
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 units
- Official record key
device-enforcement:Z-0051-2017
Official wording
Reason: The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath
Code information: 11149662, 11151447, 11151617, and 11149822.
Distribution pattern: Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.
Derived failure modes
-
Unknown
The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath