Recall Z-1428-2025 ยท DRI Monitor, Line Isolation
MEDLINE INDUSTRIES, LP - Northfield
namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
| Date | Mar 21, 2025 (initiated Feb 12, 2025) |
| Status | Open, Classified |
| Reason | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. |
| Root cause | Process change control |
| Action | Medline Industries issued two notices, delivered using email and US Mail: 1) a MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines and 2) a MEDICAL DEVICE RECALL notice for the kits containing the affected product; both notices explained the issue and the hazard. The MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines requested that the consignee destroy any affected inventory and reply to receive credit. The MEDICAL DEVICE RECALL notice for the kits containing the affected product requested the consignee respond to the notice and upon response, Medlin |
| Quantity | 4400 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.