Recall Z-0494-2015
Aircraft Medical Limited · initiated November 4, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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.
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.
FDA-determined cause: Component change control
Action taken
Aircraft Medical Limited sent a recall notification letter dated November 4, 2014 to the sole US consignee. The letter included instructions for the consignee to: 1) check its own stock and its customers' stock for the recalled products; 2) arrange for any remaining stock to be removed from use. Customers with any questions can contact Aircraft Medical by e-mail at ac@aircraftmedical.com.
Details
- Recall number
- Z-0494-2015
- Initiated
- November 4, 2014
- Posted by FDA
- December 2, 2014
- Terminated
- November 17, 2017
- Product code
- CCW – Laryngoscope, Rigid
- Quantity
- 40,900 blades (US); 16,000 blades (Foreign)
- Distribution
- 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.
- Recalling firm
- Aircraft Medical Limited, Edinburgh