Model 8100 Series Medley Medication Safety System Pump Module
FDA device recall Z-0568-05 · posted 2005-03-03 · Terminated
Recall details
- Recalling firm
- Alaris Medical Systems Inc
- Reason for recall
- The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from three (3) different customer locations.
- Action taken
- A device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 55,200
- Distribution
- United States and Canada
- Date initiated
- 2004-11-10
- Date posted
- 2005-03-03
- Date terminated
- 2005-09-02
- 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 |
|---|---|---|
| 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 |
| THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS (K950419) | Imed Corp. | 1995-06-21 |