Drug recall
CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only…
FDA recall event 67793 · Class II · Codman & Shurtleff, Inc.
Key facts
| Event ID | 67793 |
|---|---|
| Recall numbers | Z-1468-2014 |
| Recalling firm | Codman & Shurtleff, Inc. |
| Product type | Devices |
| Products | CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves. |
| Initiation date | Dec 13, 2013 |
| Report date | Apr 23, 2014 |
| Termination date | Apr 21, 2016 |
| City | Raynham |
| State | MA |
| Country | United States |
| FEI number | 3002947440 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: