Class 2 Device Recall Wound cleaning Irrigation

• Date Initiated by Firm: September 05, 2017
• Create Date: November 20, 2018
• Recall Status: Open, Classified
• Recall Number: Z-0490-2019
• Recall Event ID: 81399
• 510(K)Number: K080779
• Product Classification: Lavage, jet - Product Code FQH
• Product: Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
• Code Information: Model # FB-A-400-107 Lot Number: 4J006
• 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; 847-383-1400
• Manufacturer Reason for Recall: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
• FDA Determined Cause: Other
• Action: Firm sent recall notification letters to customers on 9/5/2017.
• Quantity in Commerce: 10,440
• Distribution: 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, PR, SC, TN, TX, UT, VA, VT, WA, and WI
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FQH and Original Applicant = IRRIMAX CORPORATION