Recall Z-1032-2023 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
| Date | Jan 27, 2023 (initiated Nov 17, 2022) |
| Status | Open, Classified |
| Reason | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. |
| Root cause | Device Design |
| Action | Medline Industries, LP notified consignees via email and first-class mail on 11/21/2022. Consignees were instructed to over-label the sterile kits with a warning label indicating Warning To Avoid Injury, Please Handle Blades with Care . For the Non-Sterile kits, they are to over label the affected kits indicating to remove the blades and replace from a different sterile supply. No product is to be returned. Customers were also instructed to complete and return the response form. |
| Quantity | 160 cases (480 units) |
| Distribution | US Nationwide distribution in the states of AR, MD, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.