Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (
FDA device recall Z-1711-2008 · posted 2008-06-10 · Terminated
Recall details
- Recalling firm
- Cardinal Health 303 Inc DBA Alaris Products
- Reason for recall
- A channel error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel errors with the Alaris System due to the Inter-Unit Interface (IUI) connectors on all Alaris System modules (manufactured on or before March 26, 2004). Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March
- Action taken
- 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). Distributors will be sent multiple copies of the Recall Notification and Customer Response Cards. The Recall letters all includeRequired Actions sections which give their customers specific information about the issue and what the customers are to do and includes a web site link for each specific problem. Each recall letter also has chart of Cardinal Health contacts support.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 77,515 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,
- Date initiated
- 2008-03-05
- Date posted
- 2008-06-10
- Date terminated
- 2011-09-13
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDLEY PCA MODULE, MODEL 8120 (K043299) | Alaris Medical Systems, Inc. | 2004-12-10 |
| MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 (K023264) | Alaris Medical Systems, Inc. | 2002-12-19 |
| MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE (K022677) | Alaris Medical Systems, Inc. | 2002-09-11 |
| GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C (K012383) | Alaris Medical Systems, Inc. | 2001-10-02 |
| MEDLEY SP02 MODULE, MODEL 8220 (K010966) | Alaris Medical Systems, Inc. | 2001-06-08 |
| THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS (K950419) | Imed Corp. | 1995-06-21 |