FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline Nursing Kit (EDUC1044) recalled for catheter defects and connector detachment risk

OTHERNationwide distribution

Medline Nursing Kit recalled for catheter defects

Medline identified quality issues in certain Nursing Kits (SKU EDUC1044) during an internal review. The catheter components did not meet specifications—including surface irregularities, connectors that detached prematurely, and some catheters that were the wrong diameter. About 730 kits were affected.

  • Check if you have a Medline Nursing Kit with SKU EDUC1044, UDI 10195327449476 or 40195327449477, and Lot 23HDA449.
  • Contact Medline or your supplier for replacement or disposal instructions.
  • Do not use the kit if you have one, as connector or catheter failure could compromise patient care.
Hazard

During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

Sold states
Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Affected count
730 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2499-2026

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