CLASS II Device recall · Reported 25 Sep 2013 · FDA Enforcement Report

Cranial Access (CRAK) Kits, Product recalled

Integra LifeSciences Corp. d.b.a. Integra Pain Management is recalling Cranial Access (CRAK) Kits, Product, distributed nationwide in the US. The recall was initiated on 4 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesINSHITH 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

Quantity recalled8,648

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2260-2013
FDA event ID: 66186
Recalling firm: Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT
Classification: Class II
Status: Terminated
Recall initiated: 4 Sep 2013
FDA classified: 19 Sep 2013
Reported: 25 Sep 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Patient Monitors

Timeline

4 Sep 2013	Recall initiated by company
19 Sep 2013	Classified by FDA	+15 days
25 Sep 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution including CA, CO, FL, IN, KS, NC, NV, NY, OK, TN, TX, VA, WA, and WI.

Nationwide California Colorado Florida Indiana Kansas North Carolina Nevada New York Oklahoma Tennessee Texas Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Nationwide Distribution including CA, CO, FL, IN, KS, NC, NV, NY, OK, TN, TX, VA, WA, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Integra LifeSciences Corp. d.b.a. Integra Pain Management

All 10

Reported	Class	Recall	Company	Reason	Where
28 Sep 2016Device	CLASS II	PHS Spinal Tray Gertie Marx recalled by Integra LifeSciences Corp.	Integra LifeSciences Corp. d.b.a. Integra Pain Management	Other	CA
14 Sep 2016Device	CLASS II	Integra Cranial Access Kits recalled by Integra LifeSciences Corp.	Integra LifeSciences Corp. d.b.a. Integra Pain Management	Packaging Defects	Nationwide
7 Sep 2016Device	CLASS II	Integra Spinal Tray recalled by Integra LifeSciences Corp.	Integra LifeSciences Corp. d.b.a. Integra Pain Management	Other	CA, OH, VA
4 Nov 2015Device	CLASS II	Integra¿ Bone Marrow Biopsy Trays recalled	Integra LifeSciences Corp. d.b.a. Integra Pain Management	Particulate Matter	MD
15 Jul 2015Device	CLASS II	Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle)ch recalled	Integra LifeSciences Corp. d.b.a. Integra Pain Management	Packaging Defects	Nationwide

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide