Z-0494-2015 Class II Terminated
FDA device recall Z-0494-2015 was initiated by Aircraft Medical Limited on November 4, 2014 and is designated Class II. 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 p… The recall status is terminated (terminated November 17, 2017). Affected quantity: 40,900 blades (US); 16,000 blades (Foreign).
Recall Details
- Product Type
- Devices
- Report Date
- December 10, 2014
- Initiation Date
- November 4, 2014
- Termination Date
- November 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,900 blades (US); 16,000 blades (Foreign)
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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the state of GA and the countries of Austria, China, Denmark, Finland, France, Hong Kong, Israel, Italy, Netherlands, Poland, Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey.
Code Information
Product Code: 350-017-000. Lot Numbers and Expiration Dates: Lot 13121202, Expires 2016/12/11; Lot 13122301, Expires 2016/12/25; Lot 13042401, Expires 2017/5/5; Lot 14030501, Expires 2017/3/16; Lot 14031814, Expires 2017/3/26; Lot 14061616, Expires 2017/6/25.