Recall Z-1303-2013 ยท LRS I.V. Start Kit
Covidien LLC
Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
| Date | May 11, 2013 (initiated Apr 12, 2013) |
| Status | Terminated |
| 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. |
| 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 | 17740 kits |
| Distribution | Worldwide distribution: USA (nationwide) and in the country of: Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842898 | CURITY I.V. START KIT The Kendal Co., Aug 17, 1984 |