Z-2909-2016Class II

Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then...

Name: Z-2909-2016 Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then...
Creator: Integra LifeSciences Corp.
Published: 2016-08-23
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2016-08-23 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary... on 2016-08-23. FDA classified it as Class II and gives the reason as "During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2909-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-23
Posted: 2016-09-30
Terminated: 2017-03-29
Recalling firm: Integra LifeSciences Corporation
Product: Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.
Quantity in commerce: 14
Distribution: Nationwide Distribution to KS only
Product codes and lots: Catalog Number 951303, Lot #0195786 with expiry 05/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2909-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2905-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30
Z-2906-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30
Z-2907-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30
Z-2908-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30
Z-2909-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30
Z-2910-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-12	2016-09-30

Product code JXG

K914995Class IICordis Straight Ventricular CatheterCordis Corp. / cleared 1992-03-09

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)