CADD-MS 3 Ambulatory Infusion Pump, Model 7400 Smiths Medical MD, Inc., St. Paul, MN 55112 USA. Electromechanical pumps
FDA device recall Z-1621-2008 · posted 2008-08-15 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- Reason for recall
- Smiths Medical discovered an issue with a motor component in specific serial numbers of the CADD-MS 3 Ambulatory Infusion Pump. This issue affects motor operation and may cause an over-delivery of medication which could result in injury to the user.
- Action taken
- Consignees were mailed an Urgent Medical Device Recall letter dated March 7, 2008. (Urgent Field Safety Notice dated March 7, 2008 for International Consignees.) The Urgent letter was addressed to "Risk & Safety Mangers, "Distributors", "Clinicians", "Patients" and "other Customers". The letter contains a Description of the Problem, Results of Investigation, and Advice on Action to be taken by the User which includes contacting Smiths Medical MD, Inc. Customer Service Department to make arrangements for a replacement pump. The letter also requests consignees to return the confirmation form.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 646
- Distribution
- Class II Recall - Worldwide Distribution --- USA including states of PA, TX, KY, FL, MN, GA, HI, NM, MD, and countries of CZ, GB, IT.
- Date initiated
- 2008-03-07
- Date posted
- 2008-08-15
- Date terminated
- 2011-12-17
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD-MS 3 AMBULATORY INFUSION PUMP (K051568) | Smiths Medical MD, Inc. | 2005-11-17 |