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Recall Observatory FDA recall evidence

Device product

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

Z-1303-2013

April 12, 2013

Class III

Product summary

Firm
Covidien LLC
Event
Event 64908
Status
Terminated
Classification
Class III
Quantity
17740 kits
Official record key
device-enforcement:Z-1303-2013

Official wording

Reason: 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.

Derived failure modes

  • 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.