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regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit

FDA Recall #Z-0293-2023 — Class II — October 20, 2022

Recall #Z-0293-2023 Date: October 20, 2022 Classification: Class II Status: Ongoing

Product Description

regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit

Reason for Recall

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Recalling Firm

ROi CPS LLC — Republic, MO

Classification

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

Product Type

Devices

Product Quantity

200 kits

Distribution

LA, MO, NC, FL

Code Information

UDI/DI 10194717079958, Lot Numbers: 92037, exp 1/31/2023; 91205, exp 6/30/2023

Status

Ongoing

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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