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U.S. Department of Health and Human Services

Class 1 Device Recall KimVent Microcuff subglottic Suctioning Endotracheal Tube

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  Class 1 Device Recall KimVent Microcuff subglottic Suctioning Endotracheal Tube see related information
Date Initiated by Firm November 17, 2014
Date Posted December 24, 2014
Recall Status1 Terminated 3 on August 18, 2015
Recall Number Z-0869-2015
Recall Event ID 69910
510(K)Number K131254  
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
Product KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC.

Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Code Information Product Code: 13224, Lot numbers: AA3274, AA3274V02, AA4062, AA4062V05, AA4092V02, AA4104V01, AA4111V03, AA4174V02 & AA4190V01.
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		 The cuff inflation line may detach from the endotracheal tube during use.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Halyard Health, sent an "URGENT: VOLUNTARY PRODUCT RECALL" letter dated November 17, 2014 via FedEx to its Consignees/customers. The letter describes the product, problem and actions to be taken. 'the customers were instructed to please evaluate your facilities for unused inventory of KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes, if present, quarantine and discontinue use; complete the attached Distributor Product Recall Response Form via fax to: 678-254-0391 within five (5) business days of receipt of this letter; if you are in possession of the affected product lots, a Halyard Health representative will provide a return authorization and instructions on shipping product to a specified distribution center, and; follow your internal product recall procedures to identify and address affected product. If you require further assistance, please call Halyard Health Regulatory Affairs at 770-587-7400.
Quantity in Commerce 80 cases (10 tubes per case)
Distribution Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.
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.
510(K) Database 510(K)s with Product Code = BTR and Original Applicant = KIMBERLY-CLARK CORP.
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