Recall Z-1063-2013— Covidien LP

Name: FDA recall Z-1063-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-11

Class II · Terminated

Class II FDA medical device recall by Covidien LP, initiated 2013-02-11, terminated 2014-03-20. It names one FDA 510(k) clearance: K111825. Product: Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.. Reason: Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention.

Recalling firm: Covidien LP
Classification: Class II
Status: Terminated
Initiated: 2013-02-11
Terminated: 2014-03-20
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K111825 — ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERSCovidien, Formerly US Surgical A Divison of Tyco H·cleared 2011-10-25

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 Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.

Reason for recall

Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention

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