CODMAN EVD BACTISEAL Catheter Sterile Packaging Defect Recall
Integra LifeSciences recalls CODMAN EVD BACTISEAL catheters due to defects in sterile packaging that may compromise product sterility. The defect affects 106 units distributed worldwide.
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: FDA Class II device with sterile barrier defect creating infection risk on intracranial catheters. Meets criterion 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Integra LifeSciences is recalling CODMAN EVD BACTISEAL 1.9mm I.D. catheter sets due to defects in the external sterile packaging. The packaging may develop gaps or weakened seals that compromise the product's sterility.
These catheters are medical devices indicated for accessing the ventricles of the brain and draining cerebrospinal fluid (CSF) to reduce intracranial pressure. The loss of sterility can increase the risk of infection in patients requiring these critical brain procedures.
The recall affects 106 units worldwide, including distribution in the United States (Texas), Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan, and Turkey. Affected lot numbers are 7314912, 7320010, and 7322933.
Healthcare facilities and patients should not use affected units. Contact Integra LifeSciences for instructions on product replacement or disposal.
The recalled product
- Product
- CODMAN EVD BACTISEAL 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 reducing…
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 106
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 (3)
- UDI-DI: 10381780518440 Lot numbers: 7314912
- 7320010
- 7322933
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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