Recall Z-1470-2022 ยท OEZ Cardiovascular Procedure Kit
MEDLINE INDUSTRIES, LP - SPT
Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS, Model Number DYNJ902880K, d. OPEN HEART A & B, Model Number DYNJ904831F, e. OPEN HEART MHS, Model Number DYNJ905394A, f. OPEN HEART MHS, Model Number DYNJ905394B, g. OPEN HEART WPH, Model Number DYNJ908168 Model/Catalog Number: Model Numbers: a. C
| Date | Jun 6, 2022 |
| Status | Open, Classified |
| Reason | Kits contain leaking bottles of isopropyl alcohol |
| Root cause | Under Investigation by firm |
| Action | The firm's consignees were notified by US mail on 06/06/2022 and instructed to destroy any affected kits on hand in accordance with their local and state regulations. |
| Quantity | 1960 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.