Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
FDA device recall Z-1303-2013 · posted 2013-05-11 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LRS
- Quantity affected
- 17740 kits
- Distribution
- Worldwide distribution: USA (nationwide) and in the country of: Panama.
- Date initiated
- 2013-04-12
- Date posted
- 2013-05-11
- Date terminated
- 2015-06-02
- Location
- Mansfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CURITY I.V. START KIT (K842898) | The Kendal Co. | 1984-08-17 |