Recall Z-2168-2019— Centurion Medical Products Corporation
Class II · Terminated
Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2019-07-01, terminated 2020-06-26. FDA's recall record names no specific 510(k) clearance for this event. Product: HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.. Reason: Potential for sterile packaging to be compromised.
- Recalling firm
- Centurion Medical Products Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-01
- Terminated
- 2020-06-26
- Firm location
- Williamston, MI, United States
Product description
HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
Reason for recall
Potential for sterile packaging to be compromised
Data sourced from openFDA. This site is unofficial and independent of the FDA.