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Class 2 Device Recall KimVent |
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Date Initiated by Firm |
January 16, 2015 |
Date Posted |
February 27, 2015 |
Recall Status1 |
Terminated 3 on July 07, 2015 |
Recall Number |
Z-1220-2015 |
Recall Event ID |
70397 |
Product Classification |
Catheters, suction, tracheobronchial - Product Code BSY
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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
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For Additional Information Contact |
Thomas Kozma, PhD 770-587-8393
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Manufacturer Reason for Recall |
Defect: A hole or crack was found which may cause air to leak.
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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
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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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