Recall Z-0490-2019— Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Name: FDA recall Z-0490-2019
Creator: U.S. Food and Drug Administration
Published: 2017-09-05

Class II · Terminated

Class II FDA medical device recall by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, initiated 2017-09-05, terminated 2024-09-23. It names one FDA 510(k) clearance: K080779. Product: Irrisept OR, Finished Bottle Assembly 450 ml STEP 1. Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents..

Recalling firm: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Classification: Class II
Status: Terminated
Initiated: 2017-09-05
Terminated: 2024-09-23
Firm location: Vernon Hills, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K080779 — IRRISEPT WOUND CLEANSING SYSTEMIrrimax Corporation·cleared 2009-02-04

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

Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

Reason for recall

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

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