Class 1 Device Recall Stolen McGRATH MAC Video Laryngoscopes

• Date Initiated by Firm: September 28, 2023
• Date Posted: November 02, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0144-2024
• Recall Event ID: 93002
• Product Classification: Laryngoscope, rigid - Product Code CCW
• Product: Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
• Code Information: Stolen defective products are not appropriately packaged and labeled - Some are missing serial numbers. UDI-DI: 10884521776494, 20884521823393. Known Affected Serial Numbers: 000063, 000076, 000085, 000092, 000093, 000112, 000120, 000121, 000146, 000153, 000154, 000155, 000166, 000179, 000190, 000197, 000202, 000224, 000233, 000238, 000255, 000308, 000329, 000375, 000389, 000436, 000446, 000455, 000464, 000465, 000497, 000512, 000526, 000528, 000546, 000553, 000597, 000607, 000628, 000641, 000648, 000650, 000673, 000677, 000745, 000752, 000753, 000760, 000764, 000769, 000781, 000809, 000810, 000821, 000823, 000847, 000850, 000871, 000879, 000887, 000891, 000913, 000914, 000918, 000939, 000958, 000960, 001015, 001027, 001135, 001140, 001191, 001211, 001348, 001355, 001385, 001418, 001446, 001491, 001504, 001534, 001555, 001561, 001596, 001605, 001621, 001629, 001631, 001669, 001760, 001826, 001829, 001859, 001952, 001985, 002008, 002016, 002017, 002037, 002042, 002056, 002151, 002160, 002174, 002197, 002234, 002242, 002279, 002282, 002291, 002294, 002321, 002322, 002363, 002386, 002480, 002676, 002777, 002780, 002786, 002793, 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• Recalling Firm/ Manufacturer: Covidien; 6135 Gunbarrel Ave; Boulder CO 80301-3214
• For Additional Information Contact: Technical Support; 800-255-6774
• Manufacturer Reason for Recall: Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation.
• FDA Determined Cause: Process control
• Action: On 9/28/23, Medtronic posted a news release on their website entitled Medtronic Notification of Stolen Defective Products - Potentially Defective McGRATH MAC Video Laryngoscopes. These affected products are defective and should not be used. Firm urges healthcare professionals to purchase products only from trusted and reliable sources, such as directly from Medtronic or its authorized distributors. To find an authorized distributor or to purchase directly from Medtronic, contact Customer Service at 800-962-9888, Option 2. The stolen defective products are not appropriately packaged and labeled. See the news release for images of conforming devices: https://news.medtronic.com/Medtronic-Notification-of-Stolen-Defective-Products-Potentially-Defective-McGRATH-TM-MAC-Video-Laryngoscopes Anyone with information regarding the promotion or sale of potentially stolen products are encouraged to contact Medtronic Customer Service at 800-962-9888, Monday through Friday from 8AM to 7PM ET.
• Quantity in Commerce: 5709
• Distribution: Unknown
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.