Home / Recalls / Medical Devices
Codman & Shurtleff, Inc. recalls Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for dr
Recalled October 29, 2014 · FDA recall Z-0091-2015 · Codman & Shurtleff
Hazard
tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus) · FDA Class II
Units
1145 units
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to: United Arab Emirates Argentina Austria Australia Aruba Belgium Bahrain Bolivia Brazil Bahamas Canada Switzerland Chile People's Republic of China Columbia Costa Rica Cyprus Czech Republic Germany Algeria Estonia Egypt Spain Finland France Gabon Great Britain French Guiana Greece Guatemala Hong Kong Croatia Hungary Ireland Israel India Iran Italy Jordan Kenya Kuwait Kazakhstan Lebanon Lithuania Luxembourg Latvia Mauritius Mexico Malaysia Mozambique New Caledonia Nigeria Netherlands Norway New Zealand Oman Panama Peru Poland Palestine Portugal Reunion Romania Serbia Russian Federation Rwanda Saudi Arabia Sweden Singapore Slovenia Slovakia Tunisia Turkey Trinadad And Tobago Taiwan Ukraine Uruguay Venezuela Mayotte South Africa
Description
tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
Product
Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
Manufacturer(s)
Codman & Shurtleff, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →