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Recall Observatory FDA recall evidence

Device product

Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 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.

Z-2190-2014

July 03, 2014

Class II

Product summary

Firm
Codman & Shurtleff, Inc.
Event
Event 68837
Status
Terminated
Classification
Class II
Quantity
9,498 devices total
Official record key
device-enforcement:Z-2190-2014

Official wording

Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).

Code information: Lot Numbers: CMBC2Z, CMBCPR, CMCC2T, CMDB7C, CMDBHC, CMJC49, CMJCMD, CMLBLZ, CMMB14, CNDBCY, CNDCV2, CNJCFT, CNKBHS, CNLB57, CNMDNL, CNNCWD, CNPB1Z, CPBB3J, CPBDBB, CPCCMO, CPDBYK

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).