MEDLINE INDUSTRIES, LP - Northfield recalls Medline Fluid Delivery Set with Drip Chamber: 1) FDS

Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.

Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RED, Item Number 949000221; 5) FDS,135,NV,MICRO-CHAMBER,W/FILTER,YELLOW, Item Number 949000223

An IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification letter dated 12/16/24 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-24-270-FG Recall Code: 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. Update: A follow-up letter titled IMMEDIATE ACTION REQUIRED dated 2/11/25 was sent to customers. Medline would like to update our action to instruct you to please destroy all impacted convenience kits and Medline will provide replacement kit(s) with the correct Fluid Delivery Set. REQUIRED ACTION: 1. Immediately check your stock for the affected kit number(s) and lot number(s) listed on the attachment. Please destroy all affected kits. 2. Please complete and return the enclosed destruction form listing the quantity of affected kits destroyed. Even if you do not have any affected product, please complete and return the form. 3. Upon receipt of your completed destruction form, Medline will issue replacem

• FDA enforcement recordOfficial FDA database entry for Z-0764-2025
• FDA 510(k) clearance · K852140The device's official FDA premarket clearance record
• FDA device classification · FPAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find MEDLINE INDUSTRIES, LP - NorthfieldSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.