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Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be ...

FDA Recall #Z-1038-2023 — Class II — December 5, 2022

Recall #Z-1038-2023 Date: December 5, 2022 Classification: Class II Status: Ongoing

Product Description

Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

Reason for Recall

Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.

Recalling Firm

Turbett Surgical, Inc. — Victor, NY

Classification

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

Product Type

Devices

Product Quantity

6 units

Distribution

US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.

Code Information

GTIN: 00859464007212 Lot Number: All Lot Numbers Serial Number: All Serial Numbers

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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