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Codman Lumbar Drainage Catheter Kit II with EDS 3… recallZ-0091-2015 · Codman & Shurtleff, Inc. · initiated Sep 15, 2014

Class II Terminated All recalls posted in October 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Codman & Shurtleff, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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)

FDA root cause category: Device Design

What the company is doing

Codman Neuro sent an Urgent Notice dated September 12, 2014, to all affected customers via overnight mailing and OUS customers notified via email the week of September 15, 2014. Accounts were requested to isolate all inventory of the affected product and return to Stericycle at the following address: Stericycle 2670 Executive Drive, Suite A Attn: Event #8894 Indianapolis, IN 46241 For patients currently being managed with the EDS 3 System, the system should be replaced immediately. In the case where no substitute drainage system is immediately available, the EDS 3 System may continue to be used until an alternative product can be obtained. If you have any questions or concerns regarding this notification, please contact your local Codman Neuro Representative or Scientific and Medical Affairs at [email protected] or (866) 685-7325. For questions regarding this recall call 508-880-8000.

Recall details

Recall number
Z-0091-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 15, 2014
Posted by the FDA
Oct 20, 2014
Recalling firm
Codman & Shurtleff, Inc.
Quantity
1145 units
Product code
JXG
FDA submissions
K061568
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

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

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

6 devices cleared under K061568 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 69262).

Sources and updates

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