Recall Z-0805-2019 ยท ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
ICU Medical, Inc.
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.
| Date | Feb 22, 2019 (initiated Jan 3, 2019) |
| Status | Terminated |
| Reason | There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate |
| Root cause | Vendor change control |
| Action | On 01/03/2019, Stericycle, Inc. sent an " URGENT: MEDICAL DEVICE RECALL" notification of the recall to ICU Medical direct consignees of record via traceable mailing. Consignees who further distributed the product were asked to notify their customers. The notification described the product, problem and actions to be taken. The consignees were instructed to do the following: 1)Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2) Inform potential users of the product in your organization of |
| Quantity | 2050 units |
| Distribution | US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131549 | CHEMOLOCK, CHEMOLOCK PORT Icu Medical, Inc., Jul 26, 2013 |