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U.S. Department of Health and Human Services

Class 2 Device Recall Turbett Surgical Container

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  Class 2 Device Recall Turbett Surgical Container see related information
Date Initiated by Firm April 14, 2022
Create Date August 04, 2022
Recall Status1 Open3, Classified
Recall Number Z-1501-2022
Recall Event ID 90578
510(K)Number K153025  
Product Classification Wrap, sterilization - Product Code FRG
Product Turbett Surgical Container, TS1500
Code Information UDI-DI (GTIN): 00859464007113; Lot No./Serial No.: 100036/2017061015, 100036/2017061016, 100036/2017061017, 100036/2017061019, 100036/2017061023, 100036/2017061025, 100065/2017121001.
Recalling Firm/
Manufacturer		 Turbett Surgical, Inc.
668b Phillips Rd Ofc 1
Victor NY 14564-9741
For Additional Information Contact Jay Schainholz
201-788-5050
Manufacturer Reason
for Recall		 Devices were subject to unapproved rework processes.
FDA Determined
Cause 2		 Process control
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 Quality@Turbettsurgical.com. 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.
Quantity in Commerce 7 units
Distribution US Nationwide Nationwide: CO, FL, NC and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRG and Original Applicant = TURBETT SURGICAL LLC
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