Class 2 Device Recall Turbett Surgical Container

• Date Initiated by Firm: April 01, 2022
• Date Posted: May 18, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1111-2022
• Recall Event ID: 90132
• 510(K)Number: K153025
• Product Classification: Wrap, sterilization - Product Code FRG
• Product: Turbett Surgical Container, TS1500
• Code Information: UDI-DI (GTIN): 00859464007113 Lot # S/N 100036 2017051001 100036 2017051004 100036 2017051005 100036 2017061018 100036 2017061026 100036 2017051000 100036 2017051003 100036 2017061021 100036 2017061022 100036 2017061020 100036 2017061011 100036 2017061012 100001 2016071009 100001 2016081005 ***Updated 7/11/22*** Lot # S/N 100036 2017051006 100036 2017051008 100181 2019081010 160522-1 2016071003 160522-1 2016071007 160522-1 2016071008 160522-1 2016071010 100004 2016091006 100004 2016091007 100065 2017121003 100065 2017121007 100125 2018010001 100125 2018010010 100099 2018011002 100099 2018011009 100099 2018011011 100099 2018031005 100099 2018031006 100099 2018031007 100083 2018031009 100083 2018031010 100083 2018031011 100083 2018031012 100083 2018031013 100099 2018081003 100099 2018081004 100099 2018081005 100099 2018081006 100099 2018081007 100099 2018081008 100099 2018081009 100099 2018081010 100099 2018091001 100099 2018091002 100099 2018091003 100099 2018091004 100099 2018091005 100099 2018091006 100099 2018091007 100099 2018091008 100125 2018111001 100125 2018111002 100125 2018111003 100125 2018111004 100125 2018111005 100125 2018111006 100125 2018111007 100125 2018111008 100125 2018111009 100125 2018111010 100125 2018111011 100125 2018111012 100125 2018111013 100125 2018111014 100130 2018121001 100130 2018121002 100125 2018121003 100130 2018121004 100130 2018121006 100130 2018121008 100130 2018121010 100130 2018121012 100130 2018121015 100130 2019011001 100130 2019011002 100130 2019011003 100130 2019011004 100130 2019011005 100130 2019011006 100130 2019011007 100130 2019011008 100130 2019011009 100130 2019011010 100130 2019021001 100130 2019021002 100130 2019021004 100130 2019021005 100130 2019021006 100130 2019021007 100130 2019021008 100130 2019021009 100150 2019031001 100150 2019031002 100150 2019031003 100150 2019031005 100150 2019031006 100150 2019031007 100150 2019031008 100150 2019031011 100150 2019031012 160522-1 2016071000 160522-1 2016071001 160522-1 2016071002 160522-1 2016071005 160522-1 2016071006 160522-1 2016071011 160522-1 2016071012 100001 2016081000 100001 2016081001 100001 2016081002 100001 2016081003 100001 2016081004 100001 2016081006 100001 2016081007 100001 2016081008 100001 2016081009 100004 2016091000 100004 2016091001 100004 2016091002 100004 2016091003 100004 2016091004 100004 2016091005 100004 2016091008 100004 2016091009 100036 2017051002 100036 2017051007 100036 2017061010 100036 2017061014 100036 2017061028 100036 2017061029 100065 2017121001 100065 2017121002 100065 2017121004 100065 2017121005 100065 2017121006 100065 2017121008 100065 2017121009 100065 2017121010 100099 2018011001 100099 2018011003 100099 2018011004 100099 2018031001 100099 2018031002 100099 2018031003 100099 2018031008 100181 2018031014 100125 2018111015 100130 2018121005 100130 2018121007 100130 2018121009 100130 2018121011 100130 2018121013 100130 2018121014 100130 2019012000 100130 2019012001 100130 2019012002 100130 2019012003 100130 2019012004 100130 2019021003 100130 2019021010 100150 2019031004 100150 2019031009 100150 2019031010 100150 2019031013 100150 2019031014 100150 2019031015 100154 2019041001 100154 2019041002 100154 2019041003 100154 2019041004 100154 2019041005 100154 2019041006 100154 2019041007 100154 2019041008 100154 2019041009 100154 2019041010 100154 2019041011 100154 2019041012 100154 2019041013 100154 2019041014 100154 2019041015 100173 2019061001 100173 2019061002 100173 2019061003 100173 2019061004 100173 2019061005 100173 2019061006 100173 2019061007 100173 2019061008 100173 2019061009 100173 2019061010 100181 2019081001 100181 2019081003 100181 2019081004 100181 2019081005 100181 2019081006 100181 2019081007 100181 2019081008 100181 2019081009 100181 2019081011 100181 2019081012 100181 2019081013 100181 2019081014 100181 2019081015 100181 2019081016 100181 2019081017 100181 2019081018 100181 2019081019 100181 2019081020 100181 2019081021 100181 2019081022 100181 2019081023 100181 2019081024 100181 2019081025 100181 2019081026 100181 2019081027 100181 2019081028 100181 2019081029 100181 2019081030 100036 2017061015 100036 2017061016 100036 2017061017 100036 2017061019 100036 2017061023 100036 2017061025 100065 2017121001 100181 2018081002 100181 2018081004
• Recalling Firm/ Manufacturer: TURBETT SURGICAL, LLC; 668b Phillips Rd Ofc 1; Victor NY 14564-9741
• For Additional Information Contact: Mr. Jay Schainholz; 201-788-5050
• Manufacturer Reason for Recall: Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
• FDA Determined Cause: Device Design
• Action: Firm notified customers on April 1, 2022 via email. Customers were instructed to immediately discontinue use of the product and quarantine the product.
• Quantity in Commerce: 232 units
• Distribution: Domestic distribution to PA, CA, and NY only.
• 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