Recall Z-1037-2023— Turbett Surgical, Inc.

Name: FDA recall Z-1037-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-05

Class II · Ongoing

Class II FDA medical device recall by Turbett Surgical, Inc., initiated 2022-12-05. It names one FDA 510(k) clearance: K153025. Product: Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. Reason: 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.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-05
Firm location: Victor, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K153025 — Turbett Surgical ContainerTurbett Surgical, LLC·cleared 2016-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Turbett Surgical Container, TS1200: 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.