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Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM

FDA Recall #Z-1071-2020 — Class II — December 11, 2019

Recall #Z-1071-2020 Date: December 11, 2019 Classification: Class II Status: Terminated

Product Description

Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM

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

100

Distribution

Nationwide Foreign: GHANA

Code Information

TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM 2019012890

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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