FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp. d.b.a. Integra Pain Management: 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.
- Recall number
- Z-0551-2014
- Recalling firm
- Integra LifeSciences Corp. d.b.a. 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.
- Status
- Terminated
- Initiated
- 2013-11-26
- Posted
- 2013-12-20
- Terminated
- 2014-04-09
- Reason
- 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
- 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
- 731
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot No. W1302120 Expires 2/1/2014 Lot No. W1305038 Expires 8/1/2015 Lot No. W1306137 Expires 9/1/2014
- 510(k) numbers
- ["K042359"]
- PMA numbers
- not on file
- Product code
- JXG
- Firm FEI
- 1000138491
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28