Integra LifeSciences Corp. d.b.a. Integra Pain Management: Medical Device Recall in 2014 - (Recall #: Z-0551-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of Cerebrospinal Fluid (CSF), and to monitor ICP. These kits contain all components and accessories required for burr hole access into the cranium.

Product Classification:

Class II

Date Initiated: November 26, 2013

Date Posted: January 1, 2014

Recall Number: Z-0551-2014

Event ID: 66949

Reason for Recall:

Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutures whose labeling does not align with the intended use and labeling of the Cranial Access Kit.

Status: Terminated

Product Quantity: 731

Code Information:

Lot No. W1302120 Expires 2/1/2014 Lot No. W1305038 Expires 8/1/2015 Lot No. W1306137 Expires 9/1/2014

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated