Recalls / —
—#117371
Product
Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.
- FDA product code
- KDD — Kit, Surgical Instrument, Disposable
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K761193
- Affected lot / code info
- 103387264, 117881264, 110983964, 214981164, 117488864
Why it was recalled
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 (FDA determination)
Error in labeling
Action the firm took
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.
Recalling firm
- Firm
- Covidien LLC
- Address
- 15 Hampshire Street, Mansfield, Massachusetts 02048-1113
Distribution
- Distribution pattern
- Worldwide distribution: USA (nationwide) and in the country of: Panama.
Timeline
- Recall initiated
- 2013-04-12
- Posted by FDA
- 2013-05-11
- Terminated
- 2015-06-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #117371. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.