Recall Z-1845-2012— Covidien LP

Name: FDA recall Z-1845-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-09

Class II · Terminated

Class II FDA medical device recall by Covidien LP, initiated 2012-05-09, terminated 2014-02-12. It names one FDA 510(k) clearance: K855047. Product: Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. Reason: Potential for the sterility barrier to be compromised..

Recalling firm: Covidien LP
Classification: Class II
Status: Terminated
Initiated: 2012-05-09
Terminated: 2014-02-12
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K855047 — AUTO SUTURE TITANIUM SURGICAL STAPLESUnited States Surgical, A Division of Tyco Healthc·cleared 1986-01-14

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

Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis

Reason for recall

Potential for the sterility barrier to be compromised.

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