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Terminated

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.

FDA Recall Z-0869-2015 · Posted 2014-12-24

Recalling FirmHalyard Health
Recall StatusTerminated
Product CodeBTR
Date Initiated2014-11-17
Date Terminated2015-08-18
Product Quantity80 cases (10 tubes per case)

Reason for Recall

The cuff inflation line may detach from the endotracheal tube during use.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K131254KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBEKimberly-Clark Corp. · 2013-08-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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