Recall Z-2186-2014— Codman & Shurtleff, Inc.
Class II · Terminated
Class II FDA medical device recall by Codman & Shurtleff, Inc., initiated 2014-07-03, terminated 2017-01-30. It names 2 FDA 510(k) clearances: K113526, K112156. Product: Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 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.. Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU)..
- Recalling firm
- Codman & Shurtleff, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-03
- Terminated
- 2017-01-30
- Firm location
- Raynham, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K113526 — CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
- K112156 — CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 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.
Reason for recall
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Data sourced from openFDA. This site is unofficial and independent of the FDA.