Recall Z-1304-2013— Covidien LLC

Name: FDA recall Z-1304-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-12

Class III · Terminated

Class III FDA medical device recall by Covidien LLC, initiated 2013-04-12, terminated 2015-06-02. It names one FDA 510(k) clearance: K761193. Product: 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..

Recalling firm: Covidien LLC
Classification: Class III
Status: Terminated
Initiated: 2013-04-12
Terminated: 2015-06-02
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K761193 — SUTURE REMOVAL KITSuperior Plastic Products Corp.·cleared 1977-01-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.