FDA recall Z-1083-2018
Centurion Medical Products Corporation · Class II · device
Product
CATHETER SECUREMENT SYSTEM
Reason for recall
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
Distribution
Nationally
Key facts
- Status
- Terminated
- Initiation date
- 2017-10-23
- Report date
- 2018-03-28
- Termination date
- 2018-06-21
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Williamston, MI, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1083-2018