Z-2260-2013Class II

Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for...

Name: Z-2260-2013 Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for...
Creator: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Published: 2013-09-04
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2013-09-04 / Terminated / root cause: packaging

FDA source

Integra LifeSciences Corp. d.b.a. Integra Pain Management began a recall of Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral... on 2013-09-04. FDA classified it as Class II and gives the reason as "Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2260-2013
Classification: Class II
Status: Terminated
Initiated: 2013-09-04
Posted: 2013-09-19
Terminated: 2014-01-28
Recalling firm: Integra Pain Management
Product: Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are 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 CSF, and to monitor ICP.
Product code: HGB Clip, Tubal Occlusion
Reason for recall: Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.
Root cause tag: packaging
FDA root cause: Packaging
Action: Integra sent an Urgent Voluntary Medical Device Recall letter dated September 4, 2013, to all affected customers that have been shipped unexpired affected product lots of Integra Cranial Access Kits, Catalogue No.'s INSHITH, INSHITHND, INSHITHRZN.The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review their inventory and immediately stop the use or distribution of any affected product. Customers were instructed to identify and report to Integra if they do or do not have any of the affected product lots. Customers were advised how to return any affected product lot numbers in their possession. Effectiveness Checks will be conducted to determine the level of customers who: - Integra has verified, have been notified, and / or acknowledged the recall either by returning the acknowledgement form. - Indicate they will be returning / have returned unexpired affected product lots of kits. Any affected product lot numbers that are returned from consignees will be forwarded to the Integra Salt Lake City, UT facility for final disposition per its site QMS processes. Customers with questions were advised to contact Customers Service at 1-855-532-1723. For questions regarding this recall call 801-886-9505.
Quantity in commerce: 8,648
Distribution: Nationwide Distribution including CA, CO, FL, IN, KS, NC, NV, NY, OK, TN, TX, VA, WA, and WI.
Product codes and lots: INSHITH Lots: W1205183,,W1207036,,W1209165,,W1209166,,W1209168,,W1210156,,W1210157,,W1210158,,W1210159,,W1210160,,W1211021,,W1211030,,W1211135,,W1211136,,W1211137,,W1212170 INSHITHND Lots: W1210230 INSHITHRZN Lots: W1209156,,W1211182,,W1212090,,W1212125,,W1212178,,W1301258,,W1302005,,W1302031,,W1303148

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2260-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2260-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-19

Product code HGB

K961113Class IICns Interchangeable Bit Cranial DrillClinical Neuro Systems, LLC / cleared 1996-06-05

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)