Z-1303-2013Class III

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

Name: Z-1303-2013 Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit
Creator: Covidien LLC
Published: 2013-04-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-04-12 / Terminated / root cause: labeling and UDI

FDA source

Covidien LLC began a recall of Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit on 2013-04-12. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1303-2013
Classification: Class III
Status: Terminated
Initiated: 2013-04-12
Posted: 2013-05-11
Terminated: 2015-06-02
Recalling firm: Medtronic, Inc.
Product: Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
Product code: LRS I.V. Start Kit
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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.
Quantity in commerce: 17740 kits
Distribution: Worldwide distribution: USA (nationwide) and in the country of: Panama.
Product codes and lots: Product 80530: 032887164, 203184264,110983764, 208286764, 116480564, 221590564, 120987864, 236385564,127085464; Product 8508: 207383964, 23489464

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1303-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1303-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11
Z-1304-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-11

Product code LRS

K842898Class IICurity i.v. Start KitThe Kendal Co. / cleared 1984-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)