Recall Z-1182-2025 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A
| Date | Feb 19, 2025 (initiated Jan 9, 2025) |
| Status | Open, Classified |
| Reason | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 1/9/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Upon receipt of your submitted response form |
| Quantity | 70 kits |
| Distribution | US States: CA, NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.