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Centurion- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1152A LA...

FDA Recall #Z-1053-2020 — Class II — December 11, 2019

Recall #Z-1053-2020 Date: December 11, 2019 Classification: Class II Status: Terminated

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

Recalling Firm

Centurion Medical Products Corporation — Williamston, MI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

N/A

Distribution

Nationwide Foreign: GHANA

Code Information

Lot Numbers: DYNDL1073 LACERATION TRAY 2019011590 DYNDL1152A LACERATION TRAY 2018122790 DYNDL1152A LACERATION TRAY 2018092090 DYNDL1223A LACERATION TRAY 2018112190 DYNDL1295B KIT,PAIN 2018112690 DYNDL1436A LACERATION TRAY 2019010490 DYNDL1436A LACERATION TRAY 2018122190 DYNDL1600B RCHSD CVP TRAY 2019030890 DYNDL1606A VAGINAL DELIVERY TRAY 2018112190 DYNDL1617A PICC INSERTION KIT-LATEX FREE 2019032190 DYNDL1617A PICC INSERTION KIT-LATEX FREE 2018120390 DYNDL1630A LACERATION TRAY 2019011090 DYNDL1675 ARTHROGRAM TRAY 2019021290 DYNDL1721 LACERATION TRAY 2019032590 DYNDL1721 LACERATION TRAY 2018100590 DYNDL1741A LACERATION TRAY 2018111390 DYNDL1744 LACERATION KIT 2018121790 DYNDL1755 LACERATION TRAY 2018121890 DYNDL1764A LACERATION TRAY 2018112190 DYNDL1772 LACERATION TRAY 2019051690 DYNDL1772 LACERATION TRAY 2018122190 DYNDL1786 SUTURING SET 2019022790 DYNDL1790 LACERATION TRAY 2019012590 DYNDL1796 LACERATION TRAY 2018101590 DYNDL1812 PEDI LACERATION TRAY 2019061090 DYNDL1840 SUTURE SET PACK 2019031490 DYNDL1847 ER SUTURE TRAY 2019051390 DYNDL1864A LACERATION TRAY 2018112790 DYNDL1897 LACERATION TRAY 2018121090 DYNDL1897 LACERATION TRAY 2018111990 DYNDL1920 LACERATION TRAY 2018101290

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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