Reported Feb 5, 2014 · Terminated
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803…
Codman & Shurtleff, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Codman & Shurtleff, Inc. · 325 Paramount Drive · Raynham, MA · 02767
Is this the product you have?
- Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal
- Catheter and Accessories Product Code82-8803
- Product UsageThe 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
- Lot codes and dates
- Lot CodesCLPCM9 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
- Amount recalled
- 431 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Codman Certas Programmable Valves used for hydrocephalus may not operate properly
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Codman & Shurtleff, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.