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FDA-Device2026-06-24Class IIPROCESSING DEFECT

Medline medical procedure kits recalled for catheter defects

Medline
OTHERNationwide distribution

Medline procedure kits recalled for catheter defects

Medline identified that certain surgical procedure kits containing catheters did not meet quality standards. Some kits had catheters with surface irregularities, connectors that could detach prematurely, or catheters that were the wrong size.

  • Check if your facility received any of the affected Medline kit SKUs (DYNJ908097, DYNJ908097A–D, DYNJ912029, DYNJ55637B, DYNJ43930A, DYNJ67767, DYNJ61136F, DYNJV0172Q, or DYNJ86229).
  • Do not use affected kits. Contact Medline with your lot numbers for instructions on return or replacement.
  • Review any procedures performed with these kits and consult clinical leadership if needed.
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
3521 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097D; 6) DR TUCKER ANT TOTAL HIP, Medline Kit Number/SKU DYNJ912029; 7) JEWISH CRANI PACK, Medline Kit Number/SKU DYNJ55637B; 8) L SCOPE PACK, Medline Kit Number/SKU DYNJ43930A; 9) LAMI PACK, Medline Kit Number/SKU DYNJ67767; 10) LAVH NEW BRAUNFELS, Medline Kit Number/SKU DYNJ61136F; 11) SOI KNEE ARTHROSCOPY, Medline Kit Number/SKU DYNJV0172Q; 12) T AND A PACK, Medline Kit Number/SKU DYNJ86229.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2508-2026

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