EVD Catheter Sterile Packaging Defect Recall for Intracranial Drainage
Integra LifeSciences is recalling CODMAN BACTISEAL EVD catheters due to external packaging seal defects that may compromise sterility. The recall affects 59 units distributed internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a high-risk sterile medical device (neurosurgical EVD catheter) where packaging defects may compromise sterility and pose infection risk. No illnesses or injuries have been reported, placing this in the 'risk-of-harm without reported injury' category per the severity rubric.
Plain-English summary
Integra LifeSciences Corp. is recalling CODMAN BACTISEAL Clear EVD (external ventricular drainage) Catheter 1.9mm I.D. Catheter Sets due to defects in the external sterile packaging pouch. The defect may cause gaps or weakness in the seal, potentially compromising the sterility of the device.
The affected product is used to access the ventricles of the brain and drain cerebrospinal fluid (CSF) to reduce intracranial pressure. The devices are used in neurosurgical procedures, where sterile product integrity is critical to patient safety.
This recall affects 59 units with lot numbers 7314916, 7314917, 7322939, 7328498, 7328563, 7328566, and 7328569. The product has been distributed worldwide, including the United States (Texas), Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan, and Turkey.
Healthcare providers who received affected units should stop using them immediately and contact Integra LifeSciences Corp. for replacement products or further guidance.
The recalled product
- Product
- CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- sterile-packaging-defect
- infection-risk
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 (7)
- UDI-DI: 10381780518457 Lot Numbers: 7314916
- 7314917
- 7322939
- 7328498
- 7328563
- 7328566
- 7328569
Distribution
Distributed nationwide across the United States.
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