Recall Z-0865-2015— Halyard Health
Class I · Terminated
Class I FDA medical device recall by Halyard Health, initiated 2014-11-17, terminated 2015-08-18. It names one FDA 510(k) clearance: K131254. 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.. Reason: The cuff inflation line may detach from the endotracheal tube during use..
- Recalling firm
- Halyard Health
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-11-17
- Terminated
- 2015-08-18
- Firm location
- Roswell, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The cuff inflation line may detach from the endotracheal tube during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.