Recall Z-1054-2015— Cardinal Health
Class II · Terminated
Class II FDA medical device recall by Cardinal Health, initiated 2014-12-23, terminated 2016-08-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.. Reason: A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube..
- Recalling firm
- Cardinal Health
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-12-23
- Terminated
- 2016-08-01
- Firm location
- Waukegan, IL, United States
Product description
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.
Reason for recall
A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.
Data sourced from openFDA. This site is unofficial and independent of the FDA.