Recall Z-1501-2022— Turbett Surgical, Inc.

Name: FDA recall Z-1501-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-14

Class II · Terminated

Class II FDA medical device recall by Turbett Surgical, Inc., initiated 2022-04-14, terminated 2025-02-20. It names one FDA 510(k) clearance: K153025. Product: Turbett Surgical Container, TS1500. Reason: Devices were subject to unapproved rework processes..

Recalling firm: Turbett Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-04-14
Terminated: 2025-02-20
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, TS1500

Reason for recall

Devices were subject to unapproved rework processes.

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