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U.S. Department of Health and Human Services

Class 2 Device Recall McGrath MAC2 Video Laryngoscope Blades

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  Class 2 Device Recall McGrath MAC2 Video Laryngoscope Blades see related information
Date Initiated by Firm November 04, 2014
Date Posted December 02, 2014
Recall Status1 Terminated 3 on November 17, 2017
Recall Number Z-0494-2015
Recall Event ID 69805
Product Classification Laryngoscope, rigid - Product Code CCW
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
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.
Recalling Firm/
Manufacturer		 Aircraft Medical Limited
9-10 SAINT ANDREW SQUARE
EDINBURGH United Kingdom
Manufacturer 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 2		 Component change control
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 ac@aircraftmedical.com.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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