Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Turbett Surgical Container, TS1500

FDA Recall Z-1501-2022 · Posted 2022-08-04

Recalling FirmTurbett Surgical, Inc.
Recall StatusTerminated
Product CodeFRG
Date Initiated2022-04-14
Date Terminated2025-02-20
Product Quantity7 units

Reason for Recall

Devices were subject to unapproved rework processes.

Firm Action

The firm distributed recall notification to hospitals via email on 04/14/2022. The recall notification identifies the reason for recall of specific TS1500 units to be that the repair process employed could restrict the customer's ability to clean and visually check the device for cleanliness. This can be identified by the customer by evidence of bioburden or particulate buildup in the seams of the device. Inadequate or incomplete cleaning of the unit may compromise the sterility of the load. The firm asks customers to immediately discontinue use of the device and complete the provided Return Response Form to [email protected]. Turbett will contact customers to coordinate the replacement of the unit and correction of the recalled device. Customers with any questions can call 585-755-0133x106 from Monday through Friday, from 8:00 AM to 4:30 PM.

Root Cause

Process control

Distribution Pattern

US Nationwide Nationwide: CO, FL, NC and PA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K153025Turbett Surgical ContainerTurbett Surgical, LLC · 2016-01-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑