Recall Z-1806-2024 ยท OEZ Cardiovascular Procedure Kit
MEDLINE INDUSTRIES, LP - Northfield
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLL
| Date | May 10, 2024 (initiated Mar 12, 2024) |
| Status | Open, Classified |
| Reason | Products have a lack of sterility assurance. |
| Root cause | Process control |
| Action | Medline issued a Medical Device Recall notice to its consignees on 03/12/2024 via email and US Mail. The notice explained the issue, potential risk, and requested destruction of the affected product. Those who further distributed the product were directed to notify those to whom they shipped the product. |
| Quantity | 570 units |
| Distribution | US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.