Class 2 Device Recall KimVent

• Date Initiated by Firm: January 16, 2015
• Date Posted: February 27, 2015
• Recall Status: Terminated on July 07, 2015
• Recall Number: Z-1220-2015
• Recall Event ID: 70397
• Product Classification: Catheters, suction, tracheobronchial - Product Code BSY
• Product: KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
• Code Information: Product Code; 2160, Lot number: M4132T636
• Recalling Firm/ Manufacturer: Halyard Health; 1400 Holcomb Bridge Rd; Roswell GA 30076-2190
• For Additional Information Contact: Thomas Kozma, PhD; 770-587-8393
• Manufacturer Reason for Recall: Defect: A hole or crack was found which may cause air to leak.
• FDA Determined Cause: Packaging process control
• Action: Consignees were notified by letter via FedEx on 01/16/2015.
• Quantity in Commerce: 5 cases (20 tubes per case)
• Distribution: CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.
• 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.