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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66353

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

Open FDA event record

Event summary

Timeline bucket
August 22, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ITC-Nexus Dx

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

Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.

Z-0137-2014
Recall number
Z-0137-2014
Initiated
August 22, 2013
Classification
Class II
Status
Terminated
Recalling firm
ITC-Nexus Dx
Quantity
6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.

Code information

Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017

Distribution pattern

Nationwide Distribution including Arizona andTexas. .