| Class 2 Device Recall KimVent | |
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
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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 |
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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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