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Terminated

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

FDA Recall Z-0494-2015 · Posted 2014-12-02

Recalling FirmAircraft Medical Limited
Recall StatusTerminated
Product CodeCCW
Date Initiated2014-11-04
Date Terminated2017-11-17
Product Quantity40,900 blades (US); 16,000 blades (Foreign)

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.

Firm Action

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 [email protected].

Root Cause

Component change control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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