Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA device recall Z-0144-2024 · posted 2023-11-02 · Open, Classified

Recall details

Recalling firm

Covidien

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

CCW

Quantity affected

5709

Distribution

Unknown

Date initiated

2023-09-28

Date posted

2023-11-02

Location

Boulder, CO