Reported Feb 5, 2014 · Terminated
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories…
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, Unitized Bactiseal
- Catheter and Accessories Product Code82-8807
- 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 CodesCLPCNB CMBCPT CMCC2W CMDB6L CMDDJV CMKB24 CMLCKN CMMC3H CMNBZH CNCB6N CNCCLJ CNCCZ3 CNDB8C CNDBRJ CNGBK4 CNHCZR CNJB1G CNJC4T CNJCMR CNKBZD CNLBVM CNLBZC CNMBFL CNNDH1 CNMBFM CNMDNK CNPBRL CNPCLV CPBBGT CNCCLH CNCCZ2 CNDB69 CNDCV0 CPBCR3 CPCBHC CPCBHD CPDCC3 CMMCGV CNBB11 CPBCR4 CPCCMN CPDBYL
- Amount recalled
- 746 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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