FDAFDA · Food and drugs·Recall number Z-2191-2014
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) for the management of hydrocephalus.
Published August 20, 2014 · Recall initiated: July 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Codman & Shurtleff, Inc.
- Distributor
- Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY; and Internationally to: Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
- Lot
- Lot Numbers: CLPCNB, CMBCPT, CMCC2W, CMDB6L, CMDDJV, CMI<B24, CMLCKN, CMMC3H, CMMCGV, CMNBZH, CNBB11, CNCB6N, CNCCLH, CNCCU, CNCCZ2, CNCCZ3, CNDB69, CNDB8C, CNDBRJ, CNDCVO, CNGBK4, CNHCZR, CNJB1G, CNJC4T, CNJCMR, CNKBZD, CNLBVM, CNLBZC, CNMBFL, CNMBFM, CNMDNK, CNNDH1, CNPBRL, CNPCLV, CPBBGT, CPBCR3, CPBCR4, CPCBHC, CPCBHD, CPCCMN, CPDBYL, CPDCC3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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