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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-1221-2015
Recall Event ID 70397
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
Product KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Code Information Product Code; 22103, Lot number: M4132T614
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 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.
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