FDAClass IIOctober 29, 2014

Codman Lumbar Drainage Catheter Kit II with EDS 3 recall

Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS)…

Why was Codman Lumbar Drainage Catheter Kit II with EDS 3 recalled?

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)

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS)…
Recalling firm
Codman & Shurtleff, Inc.
Quantity
1145 units
Distribution
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
Recall date
October 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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