Recall Z-1543-2024— Smiths Medical ASD Inc.

Name: FDA recall Z-1543-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-19

Class II · Ongoing

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2023-12-19. It names one FDA 510(k) clearance: K111386. Product: Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716. Reason: Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-19
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K111386 — MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)Smiths Medical MD, Inc.·cleared 2011-08-29

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

Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716

Reason for recall

Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.

Data sourced from openFDA. This site is unofficial and independent of the FDA.