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.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific action is to clarify pressure specifications in the Instructions for Use, which aligns with the rubric for moderate severity involving labeling or specification clarifications without reported injuries.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 9,498 units of the Codman Certas In Line Valve with Catheter and Accessories (Product Code 82-8801). The recall is issued to clarify the pressure specification for the 'virtual off' (setting 8) as outlined in the product's Instructions for Use (IFU). The device is an implantable valve used to provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus.
The affected devices were distributed worldwide, including in the United States and numerous international locations such as Canada, Australia, and various European and Middle Eastern countries. Specific lot numbers involved in the recall include CMBBP2, CMCBLG, CMDBHG, and others listed in the agency's records.
Healthcare providers and patients should consult the updated Instructions for Use to ensure the correct pressure settings are applied. This recall addresses documentation and specification clarity rather than a reported defect causing injury.
The recalled product
- 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.
- 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: CMBBP2
- CMCBLG
- CMDBHG
- CMFBB8
- CMHDFW
- CMJCPY
- CMLBLW
- CMLCKP
- CMMBCY
- CMMC3F
- CMNBFC
- CMNCDW
- CMPB96
- CNCCLK
- CNJBWO
- CNJC4B
- CNJC4W
- CNKBWN
- CNKCL1
- CNLBR3
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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