FDA (Devices) recall action 68837

Codman & Shurtleff, Inc. recalled 8 products on 2014-08-20

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2014-08-20
Critical: 0
Units: 75,984

Why these products were recalled

To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–8 of 8

ModerateFDA (Devices)··2014-08-20
Codman Certas Valve Recalled for Pressure Specification Clarification
Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.
Product
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid)
Category
Distribution
43 states
ModerateFDA (Devices)··2014-08-20
Codman Certas Valve Recalled to Clarify Pressure Specifications in Instructions
Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.
Product
Codman Certas - In line Valve with Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management o
Category
Distribution
43 states
ModerateFDA (Devices)··2014-08-20
Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use
Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.
Product
Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Category
Distribution
43 states
ModerateFDA (Devices)··2014-08-20
Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use
Codman & Shurtleff, Inc. is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.
Product
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management o
Category
Distribution
43 states
ModerateFDA (Devices)··2014-08-20
Codman Certas Valve Recalled for Pressure Specification Clarification
Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.
Product
Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management
Category
Distribution
43 states
ModerateFDA (Devices)··2014-08-20
Codman Certas Valve Recalled to Clarify Pressure Specifications in Instructions
Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.
Product
Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Category
Distribution
43 states
ModerateFDA (Devices)··2014-08-20
Codman Certas Valve Recall Clarifies Pressure Specification in Instructions
Codman & Shurtleff is recalling 9,498 implantable valves to clarify the pressure specification for the virtual off setting in the Instructions for Use.
Product
Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydroceph
Category
Distribution
43 states
ModerateFDA (Devices)··2014-08-20
Codman Certas Valve Recalled for Pressure Specification Clarification
Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the Instructions for Use.
Product
Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Category
Distribution
43 states