CODMAN BACTISEAL EVD Catheter Set: Sterile packaging defect recalled
Integra LifeSciences is recalling 135 CODMAN BACTISEAL EVD Catheter Sets due to defects in sterile packaging that may compromise product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 of a high-risk medical device used in critical neurosurgery. The packaging defect could compromise sterility and potentially lead to serious infection, though no illnesses have been reported to date. This fits the High severity criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling the CODMAN BACTISEAL EVD Catheter Set (Product Number 821745) due to defects in the external sterile packaging. The defect consists of gaps or weakness in the seal of the protective pouch, which may compromise the sterility of the device.
The CODMAN BACTISEAL EVD Catheter Set is used to access the ventricles of the brain for draining cerebrospinal fluid (CSF) and reducing intracranial pressure. The product is distributed worldwide, including the United States (primarily in Texas), Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan, and Turkey. The recall affects 135 units with lot numbers 7320001, 7320004, 720005, 7322926, and 322927.
Healthcare facilities and clinicians using this product should immediately inspect the sterile packaging of affected lots for signs of package integrity compromise, including visible gaps or seal weakening. If package integrity is questionable, the product should not be used. Contact Integra LifeSciences Corp. with questions about the recall or for replacement units.
The recalled product
- Product
- CODMAN BACTISEAL EVD 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 reducing intracranial…
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 135
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 (5)
- UDI-DI: 10381780515593 Lot numbers: 7320001
- 7320004
- 720005
- 7322926
- 322927
Distribution
Part of a larger recall action
This product is one of 3 recalled by Integra LifeSciences Corp. 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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