Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
FDA Recall Z-1303-2013 · Posted 2013-05-11
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Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeLRS
Date Initiated2013-04-12
Date Terminated2015-06-02
Product Quantity17740 kits
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.
Firm Action
US Customers were notified of the recall by letter sent by Federal Express on April 12, 2013. The letter requests that they immediately stop using any affected product, quarantine it, and return it to Covidien. Consignees were asked to return a verification form and return it to Covidien via fax.
Root Cause
Error in labeling
Distribution Pattern
Worldwide distribution: USA (nationwide) and in the country of: Panama.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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