Recall Z-2567-2025 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Number ACC010728.
| Date | Sep 19, 2025 (initiated Jul 25, 2025) |
| Status | Open, Classified |
| Reason | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended. |
| Root cause | Component design/selection |
| Action | Medline Industries issued a MEDICAL DEVICE RECALL notice to it consignees on 07/25/2025 via email and USPS first class mail. The notice explained the issue with the component within the kit, potential risk to the patient, and requested the following: REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 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 y |
| Quantity | 596 units |
| Distribution | US distribution to: AL, CA, DE, OR, TN, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.