Z-2137-2024Class II

CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and...

Name: Z-2137-2024 CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and...
Creator: Integra LifeSciences Corp.
Published: 2024-05-07
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2024-05-07 / Open, Classified / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of 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... on 2024-05-07. FDA classified it as Class II and gives the reason as "Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2137-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-07
Posted: 2024-06-12
Recalling firm: Integra LifeSciences Corporation
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 intracranial pressure and CSF volume. Product Number: 821749
Product code: JXG Shunt, Central Nervous System And Components
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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]
Quantity in commerce: 106 units
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 codes and lots: UDI-DI: 10381780518440 Lot numbers: 7314912, 7320010, 7322933

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2137-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2136-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-12
Z-2137-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-12
Z-2138-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-12

Product code JXG

K233448Class IIBactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation / cleared 2023-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)