Reported Feb 5, 2014 · Terminated
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805…
Codman & Shurtleff, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Codman & Shurtleff, Inc. · 325 Paramount Drive · Raynham, MA · 02767
Is this the product you have?
- Codman Certas Programmable Valve In Line Valve with SiphonGuard Device
- Catheter and Accessories Product Code82-8805
- Product UsageThe CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting
- Lot codes and dates
- Lot CodesCMBC2Y CMDCN9 CMJC48 CMLC6D CNCCLB CNCCZ4 CNDBRG CNDCNB CNHC8M CNJC4P CNKCL4 CNLCL1 CNMB8Y CNMDM0 CNNDHY CNPCLZ CPBC99 CPCC27 CPDBYJ CMNBFF CMNCDY CNCB6M CPBCRZ CPDCKL
- Amount recalled
- 369 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Codman Certas Programmable Valves used for hydrocephalus may not operate properly
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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