Home / Recalls / Codman & Shurtleff, Inc. / Z-0091-2015

Z-0091-2015 Class II Terminated

Recalled by Codman & Shurtleff, Inc. — Raynham, MA

FDA device recall Z-0091-2015 was initiated by Codman & Shurtleff, Inc. on September 15, 2014 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated August 11, 2017). Affected quantity: 1145 units.

Recall Details

Product Type: Devices
Report Date: October 29, 2014
Initiation Date: September 15, 2014
Termination Date: August 11, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1145 units

Product Description

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

Reason for Recall

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)

Distribution Pattern

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

Code Information

All lots with expiration on or before August 2017 (2017-08)

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