Recall Z-0941-2022 ยท CAE Airway, Oropharyngeal, Anesthesiology
MEDLINE INDUSTRIES, LP - Northfield
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
| Date | Mar 9, 2022 |
| Status | Terminated |
| Reason | The mask cuff may disconnect from the device's breathing tube. |
| Root cause | Process control |
| Action | Medline Industries, Inc. notified all affected consignees via first class mail on March 8, 2022. Medline Industries, LP. has provided each consignee with a letter and a Destruction form to record their response to the recall notification. Each Response received will be recorded and Medline Industries, LP. will send subsequent letters to consignees that have not provided a response to our recall notification in the allotted time. Each consignee was provided with a destruction form to complete and return. The consignees are responsible to destroy their product per their local and state regulat |
| Quantity | 8990 cases |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.