Recall Z-1079-2018— 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: SUTURE REMOVAL TRAY, SET or KIT. 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

SUTURE REMOVAL TRAY, SET or KIT

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.