Recall Z-0460-2008 ยท FRN Pump, Infusion
Cardinal Health 303 Inc DBA Alaris Products
Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100, Cardinal Health, San Diego, CA. (All Alaris Pump modules shipped prior to December 23, 2007 are subject to this recall)
| Date | Jan 4, 2008 (initiated Oct 29, 2007) |
| Status | Terminated |
| Reason | Inaccurate flow rate; related to misassembled (missing, bent or broken) springs during the manufacturing or servicing of the mechanism assembly |
| Root cause | Process control |
| Action | The field notification (Urgent Medical Device Recall Letter) will consist of a mailing conducted through consignees (distributors in the affected countries as well as direct customers for the Alaris Pump module (a.k.a. Medley Pump module). The domestic letters are expected to be mailed on November 5, 2007 to all of the affected accounts by return receipt mailing. A Customer Response Card will be mailed with each letter along with a Service Bulletin detailing the protocol to conduct the Occluder Pressure Test. Four (4) letters will be mailed to each account to the following titles/job functions |
| Quantity | 207,257 units |
| Distribution | Worldwide: USA including the following forty-six (46) states, along with Washington, D.C. Puerto Rico and Guam: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.