Recall Z-0089-2015— Codman & Shurtleff, Inc.
Class II · Terminated
Class II FDA medical device recall by Codman & Shurtleff, Inc., initiated 2014-09-15, terminated 2017-08-11. It names one FDA 510(k) clearance: K061568. Product: Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 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).
- Recalling firm
- Codman & Shurtleff, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-15
- Terminated
- 2017-08-11
- Firm location
- Raynham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.