Recall Z-0721-2019— Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Name: FDA recall Z-0721-2019
Creator: U.S. Food and Drug Administration
Published: 2017-09-05

Class I · Terminated

Class I FDA medical device recall by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, initiated 2017-09-05, terminated 2024-04-16. It names one FDA 510(k) clearance: K820227. Product: Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿. 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 I
Status: Terminated
Initiated: 2017-09-05
Terminated: 2024-04-16
Firm location: Vernon Hills, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K820227 — STER-O-DOSEInhalation Therapy Equipment, Co.·cleared 1982-02-23

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

Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿

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.