FDA Device recall Z-0860-2014
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CO…
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CO… by Codman And Shurtleff, citing codman Certas Programmable Valves used for hydrocephalus may not operate properly.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0860-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-16 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Codman And Shurtleff |
| Distribution | US |
Product
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 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.
Reason
Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Identifiers
| code_info | Lot Codes: CLPCM9 CMBBB2 CMBBB3 CMDBHD CMDCN7 CMDDJT CMFBNK CMFBNL CMNBZG CNDCP3 CNGBK5 CNHCZP CNJB1F CN…Lot Codes: 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0860-2014%22
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