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Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE

FDA Recall #Z-1092-2020 — Class II — December 11, 2019

Recall #Z-1092-2020 Date: December 11, 2019 Classification: Class II Status: Terminated

Product Description

Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE

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

Product/Description/Lot Numbers: SP1180 DRY PREP SET 2019032690 SP200 SKIN SCRUB TRAY 2019051390 SP415 STERILE GAUZE SPONGE 2019011090, 2018120390

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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