Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66186

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 04, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Integra LifeSciences Corp. d.b.a. Integra Pain Management

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2260-2013
Recall number
Z-2260-2013
Initiated
September 04, 2013
Classification
Class II
Status
Terminated
Quantity
8,648

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile package may become compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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