FDA-Device2013-05-22Class III

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

Covidien LLC
Hazard

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.

Sold states
Worldwide distribution: USA (nationwide) and in the country of: Panama.
Affected count
17740 kits
Manufactured in
15 Hampshire Street, Mansfield, MA, United States
Products
Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1303-2013

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