Recall Z-1641-2008 ยท FRN Pump, Infusion
Smiths Medical MD, Inc.
CADD-MS"3 Ambulatory Infusion Pumps, Model 7400, Rx only, CE 0473, SN 499000. The device is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication. Reorder Numbers 21-7401-51/49/00 & 21-7411-51
| Date | Aug 24, 2008 (initiated Feb 22, 2008) |
| Status | Terminated |
| Reason | Smiths Medical has received reports that the device powers down without an alarm. Investigation concluded that if the battery cap is not fully tightened, the pump may power down and a brief "chirp" will sound. This may occur if the user has not sufficiently tightened the battery cap or if the battery cap is damaged. If a patient is asleep or does not regularly check their Pump, there is a potentia |
| Root cause | Labeling design |
| Action | A "Smith Medical Urgent Medical Device Correction" letter dated February 22, 2008 was distributed to consignees. The letter addressed to Risk/Safety Managers, Distributors, Clinicians, Patients and other Customers, instructs them to fully tighten the battery cap and to routinely monitor the pump for damage that may result in power down situations. Consignees are to return the "Urgent Medical Device Correction" form. If you have questions about the letter or did not received the letter contact Mike Herbert at 651-628-7049 or Jeff Esselman at 651-628-7920. |
| Quantity | 2303 |
| Distribution | AZ CA FL GA HI IL KY MD MI MN NC NE NJ NM NY PA TN TX UT CANADA CHILE CZECH REPUBLIC GERMANY GREAT BRITAIN ITALY JAPAN NETHERLANDS NORWAY SWEDEN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051568 | CADD-MS 3 AMBULATORY INFUSION PUMP Smiths Medical MD, Inc., Nov 17, 2005 |