Recall Z-1080-2018— Centurion Medical Products Corporation
Class II · Terminated
Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2017-10-23, terminated 2018-06-21. FDA's recall record names no specific 510(k) clearance for this event. Product: GENERAL PURPOSE INSTRUMENT TRAY. Reason: 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..
- Recalling firm
- Centurion Medical Products Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-10-23
- Terminated
- 2018-06-21
- Firm location
- Williamston, MI, United States
Product description
GENERAL PURPOSE INSTRUMENT TRAY
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.