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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64908

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 12, 2013
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Covidien LLC

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

2 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 2

Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.

Z-1303-2013
Recall number
Z-1303-2013
Initiated
April 12, 2013
Classification
Class III
Status
Terminated
Recalling firm
Covidien LLC
Quantity
17740 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits.

Code information

Product 80530: 032887164, 203184264,110983764, 208286764, 116480564, 221590564, 120987864, 236385564,127085464; Product 8508: 207383964, 23489464

Distribution pattern

Worldwide distribution: USA (nationwide) and in the country of: Panama.

device · product 2 of 2

Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.

Z-1304-2013
Recall number
Z-1304-2013
Initiated
April 12, 2013
Classification
Class III
Status
Terminated
Recalling firm
Covidien LLC
Quantity
52363 distributed

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits.

Code information

103387264, 117881264, 110983964, 214981164, 117488864

Distribution pattern

Worldwide distribution: USA (nationwide) and in the country of: Panama.