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Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY ...

FDA Recall #Z-1066-2020 — Class II — December 11, 2019

Recall #Z-1066-2020 Date: December 11, 2019 Classification: Class II Status: Terminated

Product Description

Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH 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: TC6282G TRACHEOSTOMY CARE TRAY 2019013190 TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY 2018101690 TC7370 TRACHEOSTOMY KIT 2018121790 TC7450 DISPOSABLE TRACH TRAY 2019011690

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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