FDA Recall Open, Classified

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

Recall: Z-0144-2024 · Initiated September 28, 2023

Recall

Recall Number
Z-0144-2024
Event Number
93002
Firm
Covidien
FEI Number
2936999
Product Code
CCW
Status
Open, Classified
Root Cause
Process control
Initiated
September 28, 2023
Posted
November 2, 2023
Address
6135 Gunbarrel Ave, Boulder, CO, 80301-3214

Description

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

Reason

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

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.

Distribution

Unknown

Quantity

5709