Recall Z-1411-2021— Covidien

Name: FDA recall Z-1411-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-05

Class II · Ongoing

Class II FDA medical device recall by Covidien, initiated 2021-03-05. It names one FDA 510(k) clearance: K961771. Product: Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094. Reason: Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector..

Recalling firm: Covidien
Classification: Class II
Status: Ongoing
Initiated: 2021-03-05
Firm location: Ponce, PR, United States

510(k) clearances named in this recall

1 on FDA's record

K961771 — AUTO SUTURE SURGIWANDUnited States Surgical, A Division of Tyco Healthc·cleared 1996-09-25

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 Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094

Reason for recall

Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.

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