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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73497

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

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Event summary

Timeline bucket
February 29, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cardinal Health

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

Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.

Z-1320-2016
Recall number
Z-1320-2016
Initiated
February 29, 2016
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health
Quantity
SSI-0034: 380 units and 10-1100: 60 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp.

Code information

SSI-0034 with LOT# 462799 & 476803 10-1100 with LOT# 462788 & 485406

Distribution pattern

Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.