Integra LifeSciences Corp.: Medical Device Recall in 2016 - (Recall #: Z-2909-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 23, 2016

Date Posted: October 12, 2016

Recall Number: Z-2909-2016

Event ID: 75065

Reason for Recall:

During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

Status: Terminated

Product Quantity: 14

Code Information:

Catalog Number 951303, Lot #0195786 with expiry 05/2019

Distribution Pattern:

Nationwide Distribution to KS only

Voluntary or Mandated:

Voluntary: Firm initiated