Medical device recalls Moderate risk

Turbett Surgical, Inc. recalls Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a health…

Recall date
December 5, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1038-2023
FDA classification
Class II
Brand / firm
Turbett Surgical, Inc.
Sold / distributed
US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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