Home / Recalls / Codman & Shurtleff, Inc. / Z-2186-2014

Z-2186-2014 Class II Terminated

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

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 Unitized Catheter and Accessories; Product Code: 82-8802 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: CMBCB2, CMCBLH, CMDBHF, CMGBL5, CMJCMC, CMLBLY, CMNBZK, CNDCV1, CNHC8N, CNI<B41, CNLBR5, CNMB2Z, CNMDNN, CNNCWG, CNPB1Y, CNPCLT, CPBCRY, CPDBM1, CPFBK1

Other recalls by Codman & Shurtleff, Inc.

  • Z-2280-2019 Class II — GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm). (May 16, 2019)
  • Z-1572-2014 Class II — MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStr (November 10, 2015)
  • Z-1571-2014 Class II — MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStr (November 10, 2015)
  • Z-1684-2015 Class II — CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODM (March 5, 2015)
  • Z-0089-2015 Class II — Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System (September 15, 2014)
  • Z-0090-2015 Class II — Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage Syste (September 15, 2014)
  • Z-0091-2015 Class II — Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) C (September 15, 2014)
  • Z-2191-2014 Class II — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Cath (July 3, 2014)
  • Z-2189-2014 Class II — Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories (July 3, 2014)
  • Z-2184-2014 Class II — Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas (July 3, 2014)