Medline Oral Restoration Medical Procedure Kit recalled for catheter defects
What this means
Medline identified quality issues in representative samples of its Oral Restoration Medical Procedure Kit (SKU DYNJ86253A). Problems include irregularities in the catheter surface, premature detachment of the catheter connector, and cases where the catheter diameter did not meet specifications.
- Check if you have lot numbers 25KBC063 or 25JBO955
- Contact Medline if you have affected kits for instructions on return or replacement
- Do not use kits from these lot numbers until you confirm they are safe to use
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2490-2026More Medline recalls
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- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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