Recall Z-1542-2024— Smiths Medical ASD Inc.

Name: FDA recall Z-1542-2024
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: K040899. Product: Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E. 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

K040899 — MEDEX 3000 SERIES MR SYRINGE INFUSION PUMPMedex, Inc.·cleared 2004-04-30

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 Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E

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.