Recall Z-0859-2014
Codman & Shurtleff, Inc. · initiated May 16, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: 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. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
Codes / lots: Lot Codes: CMBBP2 CMCBLG CMDBHG CMFBB8 CMHDFW CMJCPY CMLBLW CMLCKP CMMBCY CMMC3F CMNBFC CMNCDW CMPB96 CNCCLK CNJBW0 CNJC4B CNJC4W CNKBWN CNKCL1 CNLBR3 CNLBZF CNMDM1 CNNCPL CNNDH4 CNPBRM CPBBGP CPBC97 CPBCRW CPCBHB CPCCMP CPDBYF CPBCVD CPDBYD CPDBM1 CMBCB2 CMCBLH CMDBHF CMGBL5 CMJCMC CMLBLY CMNBZK CNDCV1 CNHC8N CNKB41 CNLBR5 CNMB2Z CNMDNN CNNCWG CNPB1Y CNPCLT CPBCRY CPFBK1 CLPCM9 CMBBB2 CMBBB3 CMDBHD CMDCN7 CMDDJT CMFBNK CMFBNL CMNBZG CNDCP3 CNGBK5 CNHCZP CNJB1F CNJC4R CNJCMP CNKB0Y CNLCL0 CNMCYY CNMDNJ CNNDH0 CNPBRK CNPCLW CPBBGR CPCCBC CPCCML CPDCC2
Reason for recall
Codman Certas Programmable Valves used for hydrocephalus may not operate properly
FDA-determined cause: Device Design
Action taken
Codman issued an Urgent Notice dated May 16, 2013, to all affected customers. The letter identifed the affected product, problem and actions to be taken. Mitigation instructions are provided and if not followed or are not successful, either issue could lead to symptoms associated with under- or over-drainage. Units not implanted are to be returned. A U.S Acknowledgement Form and fax are requested to be completed and faxed to: 1-888-943-4193, or e-mail the form to codman8894@stericycle.com. If you have any questions on concerns in regards to this recall, please contact your Codman Representative or Stericycle at 1-888-943-2395.
Details
- Recall number
- Z-0859-2014
- Initiated
- May 16, 2013
- Posted by FDA
- January 29, 2014
- Terminated
- June 2, 2015
- Product code
- JXG – Shunt, Central Nervous System And Components
- Quantity
- 895 units
- Distribution
- Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
- Recalling firm
- Codman & Shurtleff, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0858-2014 Class II | Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage:…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |
| Z-0860-2014 Class II | Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |
| Z-0861-2014 Class II | Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |
| Z-0862-2014 Class II | Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |
| Z-0863-2014 Class II | Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |
| Z-0864-2014 Class II | Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |