Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the adminis
FDA device recall Z-0996-2013 · posted 2013-03-26 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
- Action taken
- On May 14th, 2010, Smiths Medical contacted the facility that received the pumps via e-mail and requested that they immediately return the pumps. The pumps were returned per Returned Goods Authorization (RGA) and exchanged for replacement pumps manufactured with plunger rod seal G6000077.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 6
- Distribution
- Distributed in the state of NH.
- Date initiated
- 2010-05-14
- Date posted
- 2013-03-26
- Date terminated
- 2013-04-11
- Location
- Saint Paul, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP (K040899) | Medex, Inc. | 2004-04-30 |