Recall Z-1211-2019— COVIDIEN LLC

Name: FDA recall Z-1211-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-13

Class II · Terminated

Class II FDA medical device recall by COVIDIEN LLC, initiated 2019-03-13, terminated 2020-04-23. It names one FDA 510(k) clearance: K903205. Product: Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles. Reason: Sterilization method used was not consistent with the labeling and the approved sterilization method.

Recalling firm: COVIDIEN LLC
Classification: Class II
Status: Terminated
Initiated: 2019-03-13
Terminated: 2020-04-23
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K903205 — AUTO SUTURE(R) ENDOSCOPIC CLAMPUnited States Surgical, A Division of Tyco Healthc·cleared 1990-10-11

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 Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles

Reason for recall

Sterilization method used was not consistent with the labeling and the approved sterilization method

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