Integra LifeSciences Corp.: Medical Device Recall in 2016 - (Recall #: Z-2908-2016)

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 Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF

Product Classification:

Class II

Date Initiated: August 23, 2016

Date Posted: October 12, 2016

Recall Number: Z-2908-2016

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: 1

Code Information:

Catalog Number 910122, Lot #0195615 with expiry 04/2019

Distribution Pattern:

Nationwide Distribution to KS only

Voluntary or Mandated:

Voluntary: Firm initiated