Skip to content
Recall Observatory FDA recall evidence

Device product

KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 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.

Z-0868-2015

November 17, 2014

Class I

Product summary

Firm
Halyard Health
Event
Event 69910
Status
Terminated
Classification
Class I
Quantity
130 cases (10 tubes per case)
Official record key
device-enforcement:Z-0868-2015

Official wording

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

Code information: Product Code: 13223, Lot numbers: AA3203V03, AA3234, AA3234V01, AA3260, AA3260V01, AA4038, AA4038V01, AA4038V02, AA4038V05, AA4077, AA4077V01, AA4083, AA4083V01, AA4092V01 & AA4125V02.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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