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U.S. Department of Health and Human Services

Class 2 Device Recall CODMAN Bactiseal EVD Catheter Set

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 Class 2 Device Recall CODMAN Bactiseal EVD Catheter Setsee related information
Date Initiated by FirmMay 07, 2024
Date PostedJune 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2137-2024
Recall Event ID 94622
510(K)NumberK233448 
Product Classification Shunt, central nervous system and components - Product Code JXG
ProductCODMAN 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 intracranial pressure and CSF volume. Product Number: 821749
Code Information UDI-DI: 10381780518440 Lot numbers: 7314912, 7320010, 7322933
FEI Number 3003418325
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information Contact: Lacey Gigante
609-275-0500
Manufacturer Reason
for Recall		Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.
FDA Determined
Cause 2		Process control
ActionIntegra issued 1st Notification- Urgent: Voluntary Medical Device Recall Letter courier service, facsimile or email between May 7th and May 9th, 2024. Letter states reason for recall, health risk and action to take: Actions to be Taken by Customers: 1. If you do have units of the affected product listed in Table 1, remove them immediately from service and quarantine them. 2. If you do have affected product, check the box on the enclosed Acknowledgement Form I do have affected product. Record the total quantity of the affected product that you have. 3. Forward this notice to those who utilize the device so they are aware of this recall and can identify any affected devices that may remain in clinical areas. 4. If you do not have affected product, check the box, I do not have affected product. 5. Complete the rest of the Acknowledgement Form and return to FCA3@integralife.com or FAX to 1-609-750-4220. 6. Keep a copy of the form for your records. 7. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. You can request a credit for the quantities returned. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com
Quantity in Commerce106 units
DistributionWorldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JXG
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