Recall Z-1505-2025 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395; 6) PEDS PURPLE, REF ACC010397; 7) NEONATAL INTUBATION TRAY, REF ACC010541A; 8) NEONATAL INTUBATION TRAY, REF ACC010541B; 9)
| Date | Apr 10, 2025 (initiated Feb 24, 2025) |
| Status | Open, Classified |
| Reason | Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical. |
| Root cause | Process change control |
| Action | Medline issued a SMITHS MEDICAL URGENT MEDICAL DEVICE CORRECTION notice on 02/24/2025 via email and letter. The notice explained the issue, potential risk, and requested the following: 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 comple |
| Quantity | 1550 units |
| Distribution | California |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213481 | Medline General Surgery Tray Medline Industries, Inc., May 24, 2022 |