Recall Z-2735-2020— Smiths Medical ASD Inc.
Class I · Ongoing
Class I FDA medical device recall by Smiths Medical ASD Inc., initiated 2020-06-26. It names 2 FDA 510(k) clearances: K111386, K040899. Product: Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.. Reason: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs..
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2020-06-26
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K111386 — MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
- K040899 — MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Reason for recall
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Data sourced from openFDA. This site is unofficial and independent of the FDA.