Recall Z-1484-06 ยท FRN Pump, Infusion
Cardinal Health 303 Inc DBA Alaris Products
Alaris SE Pump (formerly Signature Edition Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232
| Date | Sep 19, 2006 (initiated Aug 10, 2006) |
| Status | Terminated |
| Reason | This recall was initiated because of a potential for over infusion with all models of the Alaris SE Pumps (formerly the Signature Edition Infusion Pumps) caused by key bounce. |
| Root cause | Software design |
| Action | Corrective action for this recall will include notifications (five letters) being sent (Return Receipt) to all customers with affected product alerting them to this action. The letters are addressed to the Director of Biomedical Engineering, Director, Materials Management, Hospital Administration, Purchasing, and the fifth letter to the Director of Nursing. The August 15, 2006, recall letters and the warning labels will be sent return receipt requested. The verification of receipt of the notifications will be tracked and return receipt exceptions will be followed up. Follow up activities wil |
| Quantity | 147, 461 |
| Distribution | Nationwide and American Samoa, Guam, and Puerto Rico. Worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| 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 |
| K022209 | ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS Alaris Medical Systems, Inc., Aug 6, 2002 |
| K032147 | SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES Alaris Medical Systems, Inc., Jul 25, 2003 |
| K043590 | SE INFUSION SYSTEM WITH MMS Cardinal Health, Alaris Products, Mar 25, 2005 |
| K931549 | MODEL EZ-1 SING CHAN/EZ-2 DUAL CHANNEL INFUS PUMP Y, Oct 12, 1993 |