Recall Z-1065-2020— Centurion Medical Products Corporation

Name: FDA recall Z-1065-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-11

Class II · Terminated

Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2019-12-11, terminated 2020-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY ID1670 I&D TRAY ID1715 INCISION & DRAINAGE TRAY ID1765 ER I&D PACK ID1765 ER I&D PACK ID1835 I & D TRAY ID2075 I&D TRAY ID585 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY. Reason: Incomplete seals on the sterile package may compromise the sterility.

Recalling firm: Centurion Medical Products Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-12-11
Terminated: 2020-09-04
Firm location: Williamston, MI, United States

Product description

Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY ID1670 I&D TRAY ID1715 INCISION & DRAINAGE TRAY ID1765 ER I&D PACK ID1765 ER I&D PACK ID1835 I & D TRAY ID2075 I&D TRAY ID585 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY

Reason for recall

Incomplete seals on the sterile package may compromise the sterility

Data sourced from openFDA. This site is unofficial and independent of the FDA.