Home / Recalls / Codman & Shurtleff, Inc. / Z-2190-2014

Z-2190-2014 Class II Terminated

Recalled by Codman & Shurtleff, Inc. — Raynham, MA

FDA device recall Z-2190-2014 was initiated by Codman & Shurtleff, Inc. on July 3, 2014 and is designated Class II. Reason for recall: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). The recall status is terminated (terminated January 30, 2017). Affected quantity: 9,498 devices total.

Recall Details

Product Type: Devices
Report Date: August 20, 2014
Initiation Date: July 3, 2014
Termination Date: January 30, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,498 devices total

Product Description

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.

Reason for Recall

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

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.

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

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Z-2191-2014 Class II — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Cath (July 3, 2014)
Z-2184-2014 Class II — Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas (July 3, 2014)
Z-2189-2014 Class II — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories (July 3, 2014)