Recall Z-1111-2022— TURBETT SURGICAL, LLC

Name: FDA recall Z-1111-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-01

Class II · Ongoing

Class II FDA medical device recall by TURBETT SURGICAL, LLC, initiated 2022-04-01. It names one FDA 510(k) clearance: K153025. Product: Turbett Surgical Container, TS1500. Reason: Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use..

Recalling firm: TURBETT SURGICAL, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-04-01
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

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

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