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Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY ...

FDA Recall #Z-1051-2020 — Class II — December 11, 2019

Recall #Z-1051-2020 Date: December 11, 2019 Classification: Class II Status: Terminated

Product Description

Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1109 TRAY,CIRCUMCISION DYNDF1128 CIRCUMCISION 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: DYNDF1078C CIRCUMCISION TRAY 2019051390 DYNDF1082 CIRCUMCISION TRAY 2019011590 DYNDF1082 CIRCUMCISION TRAY 2018121490 DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP 2019051490 DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP 2018111490 DYNDF1109 TRAY,CIRCUMCISION 2019020690 DYNDF1128 CIRCUMCISION TRAY 2018121490

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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