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U.S. Department of Health and Human Services

Class 2 Device Recall KimVent

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  Class 2 Device Recall KimVent see related information
Date Initiated by Firm January 16, 2015
Date Posted February 27, 2015
Recall Status1 Terminated 3 on July 07, 2015
Recall Number Z-1222-2015
Recall Event ID 70397
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
Product KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Code Information Product Code; 22108147, Wet Pak Lot number: AB4195U14, AB4216U06 & AB4230U16, KimVent Lot Number: M4132T643.
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 2		 Packaging process control
Action Consignees were notified by letter via FedEx on 01/16/2015.
Quantity in Commerce 83 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.
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