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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the purpose is to clarify a specification in the Instructions for Use and does not report any illnesses or injuries, fitting the criteria for a moderate severity precautionary or labeling-related recall.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 9,498 units of the Codman Certas In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories (Product Code: 82-8806). The recall is initiated to clarify the pressure specification for the 'virtual off' (setting 8) as outlined in the product's Instructions for Use (IFU).
The affected devices are implantable medical devices used to provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. The recall covers specific lot numbers including CMBC2Z, CMBCPR, CMCC2T, and others listed in the agency documentation.
Distribution was worldwide, including the United States and numerous international markets such as Canada, Australia, and various European and Middle Eastern countries. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
The recalled product
- 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
- Manufacturer
- Codman & Shurtleff, Inc.
- Hazard
- Affected units
- 9,498
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: CMBC2Z
- CMBCPR
- CMCC2T
- CMDB7C
- CMDBHC
- CMJC49
- CMJCMD
- CMLBLZ
- CMMB14
- CNDBCY
- CNDCV2
- CNJCFT
- CNKBHS
- CNLB57
- CNMDNL
- CNNCWD
- CNPB1Z
- CPBB3J
- CPBDBB
- CPCCMO
Distribution
Part of a larger recall action
This product is one of 8 recalled by Codman & Shurtleff, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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