Recall Z-0652-2025 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
ICU Medical, Inc.
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
| Date | Dec 9, 2024 (initiated Nov 6, 2024) |
| Status | Open, Classified |
| Reason | Due to finished goods incorrectly packaged and labeled. |
| Root cause | Packaging process control |
| Action | On 11/06/2024, the firm send an "URGENT Medical Device Correction" Letter via third party (Sedgwick, Inc.) to customers informing them that product was incorrectly packaged and labeled. Product CL-80 package incorrectly contained product code CL-80S. The CL-80 is a used with a 20 mm or a 28 mm vial where as CL-80S is only use for a 20 mm vial. The issue is using the incorrect adapter may result in leakages. Actions to be taken by the Customer: Discontinue use mislabeled lot 13953938 of CL-80 and discard remaining product from this specific lot. 1. Check all inventory locations within |
| Quantity | 6000 units |
| Distribution | Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131549 | CHEMOLOCK, CHEMOLOCK PORT Icu Medical, Inc., Jul 26, 2013 |