Medical device recalls Moderate risk

TURBETT SURGICAL, LLC recalls Turbett Surgical Container, TS1500

Recall date
April 1, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1111-2022
FDA classification
Class II
Brand / firm
TURBETT SURGICAL, LLC
Sold / distributed
Domestic distribution to PA, CA, and NY only.

Why it was recalled

Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.

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, TS1500

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