Turbett Surgical Container, TS1500
Check against the official notice below — it lists the full affected range.
Turbett Surgical, LLC is recalling 232 Turbett Surgical Container TS1500 units distributed to Pennsylvania, California, and New York. Eight units manufactured before June 2019 developed weld failures that breached the sterile barrier after prolonged use. The affected products can be identified by their UDI-DI (GTIN) number 00859464007113 and multiple lot and serial numbers listed in the recall notice, with the most recent lot information updated on July 11, 2022.
The recall source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
Reason for recall: Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use. Distribution: Domestic distribution to PA, CA, and NY only. Quantity: 232 units Lot/code info: 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 201901100
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.