Z-0551-2014Class II

Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for...

Name: Z-0551-2014 Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for...
Creator: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Published: 2013-11-26
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2013-11-26 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. d.b.a. Integra Pain Management began a recall of 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... on 2013-11-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0551-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-26
Posted: 2013-12-20
Terminated: 2014-04-09
Recalling firm: Integra Pain Management
Product: 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 code: JXG Shunt, Central Nervous System And Components
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Integra sent an Urgent Voluntary Medical Device Recall letter dated November 26, 2013, to all affected consignees. The letter identified the product, the problem, the action to be taken by the consignee and included a Recall Acknowledgement and Return form. Consignees were instructed to review their inventory and determine if they have any affected product, stop using the affected product immediately and remove from service. Consignees were instructed to complete the attached form even if they do not have the affected product in their inventory and return by email or fax as indicated on the form. When the form is received Customer Service will send an RMA number and directions to return the product. Customers with questions were instructed to contact Customer Service at 1-855-532-1723 or their Integra sales representative at 909-201-4099. For questions regarding this recall call 609-936-6822.
Quantity in commerce: 731
Distribution: Nationwide Distribution
Product codes and lots: Lot No. W1302120 Expires 2/1/2014 Lot No. W1305038 Expires 8/1/2015 Lot No. W1306137 Expires 9/1/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0551-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0551-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-20

Product code JXG

K042359Class IISubdural Evacuating Port System Cranial Access Kit (Seps-Ca), (Seps-Cal), (Seps-Cand),models 11-0401 Ca, 11-0401-CalMedical Designs, LLC / cleared 2004-11-17

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)