Recall Z-0156-2025 ยท OEZ Cardiovascular Procedure Kit
MEDLINE INDUSTRIES, LP - Northfield
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ32727A; a) VASCULAR PACK-LF, REF DYNJ32915B; a) SUAREZ AVR/MVR PACK, REF DYNJ35884C; a) VALVE ACCESSORY PACK, REF DYNJ36241K;
| Date | Oct 23, 2024 (initiated Sep 4, 2024) |
| Status | Open, Classified |
| Reason | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. |
| Root cause | Under Investigation by firm |
| Action | Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees. |
| Quantity | 2631 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.