Codman EDS 3 Drainage System Recalled for Potential CSF Leakage
Codman & Shurtleff is recalling EDS 3 Drainage Systems because tubing may leak or disconnect, risking improper fluid drainage or air introduction.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect in a medical device that can lead to significant physiological consequences, such as pneumocephalus or improper drainage, fitting the 'Severe' criteria for significant injury risk or structural defects.
Plain-English summary
Codman & Shurtleff, Inc. is recalling the Codman EDS 3 Drainage System with Ventricular Catheter (Catalog Number 82-1730). The recall involves 66,120 units with expiration dates on or before August 2017. These devices are indicated for draining cerebrospinal fluid (CSF) to reduce intracranial pressure when a permanent internal shunt is not indicated.
The recall is due to a defect where the tubing within the system may leak or disconnect from the joints. This failure may result in over- or under-drainage of CSF from the ventricular system or the introduction of air into the ventricular system, a condition known as pneumocephalus.
The affected products were distributed worldwide, including nationwide in the United States and to numerous international locations. Healthcare providers and patients should stop using the affected devices and contact Codman & Shurtleff, Inc. for further instructions.
The recalled product
- 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 i
- Manufacturer
- Codman & Shurtleff, Inc.
- Affected units
- 66,120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots with expiration on or before August 2017 (2017-08)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Codman & Shurtleff, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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