Recall Z-1053-2020— Centurion Medical Products Corporation
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- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1223A LACERATION TRAY DYNDL1295B KIT,PAIN DYNDL1436A LACERATION TRAY DYNDL1436A LACERATION TRAY DYNDL1600B RCHSD CVP TRAY DYNDL1606A VAGINAL DELIVERY TRAY DYNDL1617A PICC INSERTION KIT-LATEX FREE DYNDL1617A PICC INSERTION KIT-LATEX FREE DYNDL1630A LACERATION TRAY DYNDL1675 ARTHROGRAM TRAY DYNDL1721 LACERATION TRAY DYNDL1721 LACERATION TRAY DYNDL1741A LACERATION TRAY DYNDL1744 LACERATION KIT DYNDL1755 LACERATION TRAY DYNDL1764A LACERATION TRAY DYNDL1772 LACERATION TRAY DYNDL1772 LACERATION TRAY DYNDL1786 SUTURING SET DYNDL1790 LACERATION TRAY DYNDL1796 LACERATION TRAY DYNDL1812 PEDI LACERATION TRAY DYNDL1840 SUTURE SET PACK DYNDL1847 ER SUTURE TRAY DYNDL1864A LACERATION TRAY DYNDL1897 LACERATION TRAY DYNDL1897 LACERATION TRAY DYNDL1920 LACERATION 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- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1223A LACERATION TRAY DYNDL1295B KIT,PAIN DYNDL1436A LACERATION TRAY DYNDL1436A LACERATION TRAY DYNDL1600B RCHSD CVP TRAY DYNDL1606A VAGINAL DELIVERY TRAY DYNDL1617A PICC INSERTION KIT-LATEX FREE DYNDL1617A PICC INSERTION KIT-LATEX FREE DYNDL1630A LACERATION TRAY DYNDL1675 ARTHROGRAM TRAY DYNDL1721 LACERATION TRAY DYNDL1721 LACERATION TRAY DYNDL1741A LACERATION TRAY DYNDL1744 LACERATION KIT DYNDL1755 LACERATION TRAY DYNDL1764A LACERATION TRAY DYNDL1772 LACERATION TRAY DYNDL1772 LACERATION TRAY DYNDL1786 SUTURING SET DYNDL1790 LACERATION TRAY DYNDL1796 LACERATION TRAY DYNDL1812 PEDI LACERATION TRAY DYNDL1840 SUTURE SET PACK DYNDL1847 ER SUTURE TRAY DYNDL1864A LACERATION TRAY DYNDL1897 LACERATION TRAY DYNDL1897 LACERATION TRAY DYNDL1920 LACERATION 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.