Recall Z-1712-2008 ยท FRN Pump, Infusion
Cardinal Health 303 Inc DBA Alaris Products
U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe module) (2) Alaris PCA module (Model 8120) (a.k.a. Medley PCA module), CardinalHealth, San Diego, CA 92130
| Date | Jun 10, 2008 (initiated Mar 5, 2008) |
| Status | Terminated |
| Reason | A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors due to failure of the U9 Socketed Integrated Circuits (U9 IC) on the display board of the Alaris Syringe Module ("Syringe module") and Alaris PCA module ("PCA module") for modules manufactured on or before October 4, 2005. The user will be required to re |
| Root cause | Device Design |
| Action | An Urgent Medical Device Recall Notification letter was sent to consignees on April 10, 2008. Four customer letters were issued. The U19 IC issue affects only the Pump module and the U9 IC issue affects only the Syringe and PCA modules. Therefore there will be one letter for customers affected by all three issues Ul9 IC, U9 IC, and the IUI, one letter for affected Ul9 IC and U9 IC customers, one letter for U19 IC-only customers and one letter for U9 IC-only customers. All mailings were conducted through consignees (distributors as well as direct customers for the affected devices). Distrib |
| Quantity | 8,286 units |
| Distribution | Class II Recall - Worldwide Distribution --- USA including states of AR, AZ, CA, CT, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI and WY, Guam and country of Canada. ****CDRH Comments: "Note for District Off |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010966 | MEDLEY SP02 MODULE, MODEL 8220 Alaris Medical Systems, Inc., Jun 8, 2001 |
| K012383 | GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C Alaris Medical Systems, Inc., Oct 2, 2001 |
| K022677 | MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE Alaris Medical Systems, Inc., Sep 11, 2002 |
| K023264 | MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 Alaris Medical Systems, Inc., Dec 19, 2002 |
| K043299 | MEDLEY PCA MODULE, MODEL 8120 Alaris Medical Systems, Inc., Dec 10, 2004 |
| K950419 | THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS Imed Corp., Jun 21, 1995 |