—#211711

Product

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

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K852140
Affected lot / code info: 1)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000128741; 2)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000134505; 3)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000133893; 4)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000135769; 5)99000069UDI-D:10193489069587(each)30193489069581(case), Lot Number:0000139596; 6)949000222UDI-D:10197344018550(each)30197344018554(case), Lot Number:0000133018; 7)949000224UDI-D:10197344018642(each)30197344018646(case), Lot Number:0000136573; 8)949000221UDI-D:10197344018567(each)30197344018561(case), Lot Number:0000133036; 9)949000223UDI-D:10197344018543(each)30197344018547(case), Lot Number:0000133031;

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2024-12-16
Posted by FDA: 2025-01-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211711. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.