Recall Z-0144-2024 ยท CCW Laryngoscope, Rigid
Covidien
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
| Date | Nov 2, 2023 (initiated Sep 28, 2023) |
| Status | Open, Classified |
| 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. |
| Root 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 l |
| Quantity | 5709 |
| Distribution | Unknown |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.