Device product
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 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-0866-2015
Product summary
- Firm
- Halyard Health
- Event
- Event 69910
- Status
- Terminated
- Classification
- Class I
- Quantity
- 430 cases (10 tubes per case)
- Official record key
device-enforcement:Z-0866-2015
Official wording
Reason: The cuff inflation line may detach from the endotracheal tube during use.
Code information: Product Code: 13221, Lot numbers: AA3213, AA3213V01, AA3231, AA3231V01, AA3249, AA3249V02, AA3253, AA3253V01, AA3274, AA3274V03, AA4062, AA4062V02, AA4062V06, AA4097, AA4097V01, AA4097V03, AA4125V01, AA4134V02, AA4140, AA4140V01, AA4142, AA4142V01, AA4146V02, AA4167V03, AA4170 & AA4170V02.
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
The cuff inflation line may detach from the endotracheal tube during use.