FDA Device recall Z-0091-2015
Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal f…
- FDA Device
- Class II
- terminated
- Published 2014-10-29
On 2014-10-29 the FDA classified a Class II recall of Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal f… by Codman And Shurtleff, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0091-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-15 |
| Published | 2014-10-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Codman And Shurtleff |
| Distribution | US |
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
Reason
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)
Identifiers
| code_info | All lots with expiration on or before August 2017 (2017-08) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0091-2015%22
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