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NAMIC recallZ-0764-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Dec 16, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected]. 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

Recall details

Recall number
Z-0764-2025
Status
Open, Classified
Initiated by the company
Dec 16, 2024
Posted by the FDA
Jan 15, 2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
13,600 units
Product code
FPA
FDA submissions
K852140
Distribution
US Nationwide Distribution

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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;

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

1 device cleared under K852140 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95988).

Sources and updates

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