FDA Enforcement
Class III
Terminated
Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.
Recall: Z-1304-2013
·
Reported May 22, 2013
Enforcement
- Recall Number
- Z-1304-2013
- Event ID
- 64908
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Covidien LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 22, 2013
- Initiation Date
- April 12, 2013
- Classification Date
- May 11, 2013
- Termination Date
- June 2, 2015
- Address
- 15 Hampshire Street, Mansfield, MA, 02048-1113, United States
Description
Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.
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.
Code Info
103387264, 117881264, 110983964, 214981164, 117488864
Distribution
Worldwide distribution: USA (nationwide) and in the country of: Panama.
Quantity
52363 distributed