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Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRA...

FDA Recall #Z-1055-2020 — Class II — December 11, 2019

Recall #Z-1055-2020 Date: December 11, 2019 Classification: Class II Status: Terminated

Product Description

Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2610 PELVIC EXAM TRAY PE2700 ULTRASOUND TRAY PE2700 ULTRASOUND TRAY PE2820 VAG/VIRGIN VAG EXAM TRAY PE2835 PELVIC EXAM TRAY PE2835 PELVIC EXAM TRAY PE2905 HSG TRAY PE2955 7PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE3125 PELVIC EXAM TRAY PE3195 PELVIC EXAM TRAY PE3285 PELVIC EXAM TRAY PE3360 PELVIC EXAM TRAY W/LIGHT PE3375 PELVIC EXAM TRAY PE3400 MEDIUM GYN EXAM TRAY PE3475 IUD TRAY PE3585 MEDIUM/LARGE PELVIC EXAM TRAY PE860 VAGINAL BLEEDER KIT

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: PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2610 PELVIC EXAM TRAY PE2700 ULTRASOUND TRAY PE2700 ULTRASOUND TRAY PE2820 VAG/VIRGIN VAG EXAM TRAY PE2835 PELVIC EXAM TRAY PE2835 PELVIC EXAM TRAY PE2905 HSG TRAY PE2955 7PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE2965 DISPOSABLE PELVIC EXAM TRAY PE3125 PELVIC EXAM TRAY PE3195 PELVIC EXAM TRAY PE3285 PELVIC EXAM TRAY PE3360 PELVIC EXAM TRAY W/LIGHT PE3375 PELVIC EXAM TRAY PE3400 MEDIUM GYN EXAM TRAY PE3475 IUD TRAY PE3585 MEDIUM/LARGE PELVIC EXAM TRAY PE860 VAGINAL BLEEDER KIT

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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