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Regard, T AND A - Rogers, sterilized convenience kits

FDA Recall #Z-0469-2022 — Class II — November 30, 2021

Recall #Z-0469-2022 Date: November 30, 2021 Classification: Class II Status: Terminated

Product Description

Regard, T AND A - Rogers, sterilized convenience kits

Reason for Recall

Kits lacks rubber latex warning label.

Recalling Firm

ROi CPS LLC — Republic, MO

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

195 kits

Distribution

US Nationwide distribution in the state of MO.

Code Information

1) Item Number 8800313004, Lot Number 89090D (UDI 10194717110804); Expiration 07/15/2023 2) Item Number 8800313005, Lot Number 89378 (UDI 10194717112730); Expiration 08/05/2023

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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