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CODMAN BACTISEAL recallZ-2136-2024 · Integra LifeSciences Corp. · initiated May 7, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.

FDA root cause category: Process control

What the company is doing

Integra 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 [email protected] 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: [email protected]

Recall details

Recall number
Z-2136-2024
Status
Open, Classified
Initiated by the company
May 7, 2024
Posted by the FDA
Jun 12, 2024
Recalling firm
Integra LifeSciences Corp.
Quantity
135 units
Product code
JXG
FDA submissions
K233448
Distribution
Worldwide - 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

Product description

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 pressure and CSF volume. Product Number: 821745

Code information (models, lots, serial numbers)

UDI-DI: 10381780515593 Lot numbers: 7320001, 7320004, 720005, 7322926, 322927

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94622).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page