FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline DR FERNANDEZ medical procedure kit recalled for catheter defects

OTHERNationwide distribution

Medline DR FERNANDEZ kit recalled for catheter defects

Medline identified quality issues in specific lots of its DR FERNANDEZ medical procedure kits. The catheter components had surface irregularities, connectors that detached prematurely, and diameter measurements that didn't meet specifications.

  • Check if you have kit number DYNJ68808 with lot numbers 21LBT965, 21IBU081, 21GBN159, or 21DBC976.
  • Do not use affected kits; contact Medline or your healthcare provider for replacement or guidance.
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
91 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2498-2026

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