| Class 1 Device Recall KimVent Microcuff subglottic Suctioning Endotracheal Tube |  |
Date Initiated by Firm | November 17, 2014 |
Date Posted | December 24, 2014 |
Recall Status1 |
Terminated 3 on August 18, 2015 |
Recall Number | Z-0865-2015 |
Recall Event ID |
69910 |
510(K)Number | K131254 |
Product Classification |
Tube, tracheal (w/wo connector) - Product Code BTR
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Product | KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 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: 13220, Lot numbers: AA3213, AA3227, AA3227V01, AA3245, AA3245V02, AA3253V02, AA3269V01, AA3274V01, AA4038, AA4038V03, AA4038V04, AA4038V06, AA4062, AA4062V01, AA4104V02, AA4111V01, AA4113V01, AA4134V01 & AA4146V01, AA4146V04, AA4174V01. |
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 |
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 | 250 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 |
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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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510(K) Database | 510(K)s with Product Code = BTR
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