Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Pr
FDA device recall Z-0860-2014 · posted 2014-01-29 · Terminated
Recall details
- Recalling firm
- Codman & Shurtleff, Inc.
- Reason for recall
- Codman Certas Programmable Valves used for hydrocephalus may not operate properly
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 431 units
- Distribution
- Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal,
- Date initiated
- 2013-05-16
- Date posted
- 2014-01-29
- Date terminated
- 2015-06-02
- Location
- Raynham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM (K113526) | Medos International SARL | 2012-02-16 |
| CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM (K112156) | Medos International SARL | 2011-10-17 |