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FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline cardiac surgery kits recalled for catheter defects

Medline
OTHERNationwide distribution

Medline cardiac procedure kits recalled for catheter defects

Medline Industries identified that samples of multiple cardiac and vascular surgery kits did not meet performance standards. The kits contained catheters with surface irregularities, connectors that could detach prematurely, and in some cases, outer diameters that were out of specification.

  • Check your facility's inventory against the affected kit SKUs and lot numbers listed in the recall notice
  • Do not use affected kits; contact Medline for instructions on return or replacement
  • Notify your surgical team and relevant departments about the recall
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
4801 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) CARDIAC SURGERY, Medline Kit/SKU DYNJ911589A; 3) CAROTID ENDARTECOMY, Medline Kit/SKU DYNJ36211D; 4) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973; 5) CHLA ECMO / CARDIAC PACK, Medline Kit/SKU DYNJ87973A; 6) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879; 7) CV PART 1 AND 2, Medline Kit/SKU DYNJ908879C; 8) FEM POP CDS, Medline Kit/SKU CDS983670K; 9) LAP BASIN TRAY, Medline Kit/SKU DYNJ50908B; 10) OPEN HEART LTX CATHETERS KIT, Medline Kit/SKU DYNJ0049032A; 11) OPEN HEART PACK, Medline Kit/SKU DYNJ80549C; 12) OPEN HEART PACK, Medline Kit/SKU DYNJ80549D; 13) RR-ADULT ECMO PACK, Medline Kit/SKU DYNJ69742B; 14) TAVR, Medline Kit/SKU DYNJ906509C.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2486-2026

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