Recall Z-2662-2018— Smiths Medical ASD Inc.
Class II · Terminated
Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2018-04-13, terminated 2023-01-30. It names 2 FDA 510(k) clearances: K111386, K040899. Product: Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism. Reason: Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe..
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-13
- Terminated
- 2023-01-30
- 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 Infusion Pump, containing the Barrel Clamp Guide mechanism
Reason for recall
Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.
Data sourced from openFDA. This site is unofficial and independent of the FDA.