FDAFDA · Food and drugs·Recall number Z-0869-2015
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.
Published December 31, 2014 · Recall initiated: November 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The cuff inflation line may detach from the endotracheal tube during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Halyard Health
- Distributor
- 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.
- Lot
- Product Code: 13224, Lot numbers: AA3274, AA3274V02, AA4062, AA4062V05, AA4092V02, AA4104V01, AA4111V03, AA4174V02 & AA4190V01.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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