Smiths Medical, Medfusion 3500 Syringe Pumps, Software version 5.0.0, Rx Only. These pumps are indicated for use by heal
FDA device recall Z-1206-2012 · posted 2012-03-14 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Pumps rendered inoperable at power up (displaying a blank screen and alarm).
- Action taken
- 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 for repair, as and when needed. As of December 2011, The hospital has returned 67 devices to Smiths Medical. For questions regarding this recall call 651-628-7477.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 595 (WI )+ 864 (DC) = 1459
- Distribution
- Nationwide Distribution including WI and DC
- Date initiated
- 2012-01-02
- Date posted
- 2012-03-14
- Date terminated
- 2013-07-25
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP (K040899) | Medex, Inc. | 2004-04-30 |