Recall Z-1206-2012 ยท FRN Pump, Infusion
Smiths Medical ASD, Inc.
Smiths Medical, Medfusion 3500 Syringe Pumps, Software version 5.0.0, Rx Only. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.
| Date | Mar 14, 2012 (initiated Jan 2, 2012) |
| Status | Terminated |
| Reason | Pumps rendered inoperable at power up (displaying a blank screen and alarm). |
| Root cause | Vendor change control |
| Action | Smiths Medical ASD, Inc. contacted two consignees by telephone in November 2010 and January 2011. Smiths Medical worked with one of the two customers to correct 540 of the 595 devices (91%) while on-site in January 2011. The remaining devices were corrected by hospital personnel. The other customer was also made aware of the issue, root cause and corrective action. This customer reported to Smiths Medical that they understood the issue, but did not want Smiths Medical to perform the correction on their pumps at the time (January 2011). They preferred to send their pumps to Smiths Medical f |
| Quantity | 595 (WI )+ 864 (DC) = 1459 |
| Distribution | Nationwide Distribution including WI and DC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP Medex, Inc., Apr 30, 2004 |