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.
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 indicates the action is to clarify a specification in the Instructions for Use rather than address a reported defect or injury, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 9,498 units of the Codman Certas In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories (Product Code: 82-8807). The recall is initiated to clarify the pressure specification for the 'virtual off' setting (setting 8) as outlined in the product's Instructions for Use (IFU).
The affected devices are implantable valves used to provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus. The recall covers devices distributed worldwide, including the United States and numerous international markets such as Canada, Australia, and various European and Middle Eastern countries.
Healthcare providers and patients should refer to the updated Instructions for Use for the correct pressure specifications regarding the virtual off setting. No specific instructions for consumer action are provided in the source text beyond the clarification of the IFU.
The recalled product
- 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)
- 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: CLPCNB
- CMBCPT
- CMCC2W
- CMDB6L
- CMDDJV
- CMI<B24
- CMLCKN
- CMMC3H
- CMMCGV
- CMNBZH
- CNBB11
- CNCB6N
- CNCCLH
- CNCCU
- CNCCZ2
- CNCCZ3
- CNDB69
- CNDB8C
- CNDBRJ
- CNDCVO
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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