Recall Z-2734-2020— 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 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1. 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 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
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.