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Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790

FDA Recall #Z-1068-2020 — Class II — December 11, 2019

Recall #Z-1068-2020 Date: December 11, 2019 Classification: Class II Status: Terminated

Product Description

Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790

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

67465 STERILE SIMS UTERINE SOUND (83360) 2019032790

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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