Recall Z-1591-2025 ยท OES Cardiac Catheterization Kit
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH PACK, Model Number: DYNJ51338C; 6) BRISTOL MYELOGRAM, Model Number: DYNDH1228; 7) CARDIAC CATH-LEFT HEART, Model Number: DY
| Date | Apr 17, 2025 (initiated Mar 3, 2025) |
| Status | Open, Classified |
| Reason | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| Root cause | Under Investigation by firm |
| Action | An IMMEDIATE ACTION REQUIRED MEDLINE DEVICE RECALL notification letter dated 3/3/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 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 you do not have any affected product in inventory, please complete and submit the response form. 3.Please destroy any affected inventory. Medline will issue credit for the |
| Quantity | 4022 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.