Recall Z-1430-2025 ยท OEQ Angiography/Angioplasty Kit
MEDLINE INDUSTRIES, LP - Northfield
namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
| 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 | 100 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.