Medline DR FERNANDEZ medical procedure kit recalled for catheter defects
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.
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-2498-2026More Medline recalls
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