RegWardenFDA facility compliance records
Recall

Class III — Covidien LLC

Recalling firmCovidien llc
Registered facilityView this company's 22 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass III
StatusTerminated
ReasonOn 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.
ProductCurity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
Quantity17740 kits
DistributionWorldwide distribution: USA (nationwide) and in the country of: Panama.
Initiated2013-04-12
Classified2013-05-11
Terminated2015-06-02
Recall numberZ-1303-2013
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class III recall — Covidien LLC (Z-1303-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64908/

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