Integra LifeSciences Corp.: Medical Device Recall in 2016 - (Recall #: Z-2905-2016)

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 Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves

Product Classification:

Class II

Date Initiated: August 23, 2016

Date Posted: October 12, 2016

Recall Number: Z-2905-2016

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: 10

Code Information:

Catalog Number VC-1, Lot #0195451 with expiry 05/2019

Distribution Pattern:

Nationwide Distribution to KS only

Voluntary or Mandated:

Voluntary: Firm initiated