Codman & Shurtleff, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2184-2014)
See the recall detail below. You can also see other recalls from the same firm in 2014.
Codman Certas - In Line Valve Only; Product Code: 82-8800 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.
Class II
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Lot Numbers: CLNCB1, CMBBP1, CMBCPN, CMCBWG, CMCC2V, CMDCN8, CMDDJN, CMGB8H, CMI<B21, CMJCL8, CMJCPW, CMMCGR, CMNBFB, CMNBZJ, CMNC8T, CMNCYL, CMPB4V, CNBBCV, CNCB6W, CNCCPF, CNDBCW, CNDBRH, CNDCJ2, CNFCK7, CNGBG0, CNGBI<2, CNGBRY, CNHB95, CNHCKH, CNHCZN, CNJBW5, CNJBWZ, CNJC38, CNJC4I<, CNJCD3, CNJCFR, CNJCMN, CNKBWP, CNKCC8, CNKCL3, CNLBR6, CNLCL3, CNLCW3, CNNCWF, CNNDCK, CNPB1R, CNPB1T, CNPBML, CNPBRH, CNPCLR, CPBB3G, CPBC96, CPBCCR, CPBCRV, CPCBG8, CPCBG9, CPCCBH, CPCCM1, CPCCMK, CPCCMZ, CPDBYC, CPDC07, CPDCC7, CPFBKP
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.
Voluntary: Firm initiated