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