Recall Z-0494-2015— Aircraft Medical Limited
Class II · Terminated
Class II FDA medical device recall by Aircraft Medical Limited, initiated 2014-11-04, terminated 2017-11-17. FDA's recall record names no specific 510(k) clearance for this event. Product: McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes. Reason: The blade retaining clip may be difficult to engage and thereby increase the possibility of a blade becoming disconnected during intubation, specifically when the device is being retracted from the patients mouth..
- Recalling firm
- Aircraft Medical Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-04
- Terminated
- 2017-11-17
- Firm location
- EDINBURGH, N/A, United Kingdom
Product description
McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes
Reason for recall
The blade retaining clip may be difficult to engage and thereby increase the possibility of a blade becoming disconnected during intubation, specifically when the device is being retracted from the patients mouth.
Data sourced from openFDA. This site is unofficial and independent of the FDA.