Class 1 Device Recall Sterile Water for Inhalation

• Date Initiated by Firm: September 05, 2017
• Date Posted: February 04, 2019
• Recall Status: Terminated on April 16, 2024
• Recall Number: Z-0719-2019
• Recall Event ID: 81021
• 510(K)Number: K820227
• Product Classification: Nebulizer (direct patient interface) - Product Code CAF
• Product: Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ; ; ¿
• Code Information: Model # R0059 Lot Number: ¿B360
• Recalling Firm/ Manufacturer: Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company; 330 Corporate Woods Pkwy; Vernon Hills IL 60061-3107
• For Additional Information Contact: Christine Thomas; 763-383-3048
• Manufacturer Reason for Recall: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
• FDA Determined Cause: Process control
• Action: Firm sent recall notification letters to customers on 9/5/2017.
• Quantity in Commerce: 102,000
• Distribution: Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CAF and Original Applicant = INHALATION THERAPY EQUIPMENT, CO.