Medline Tonsil Pack Cath medical procedure kits recalled for catheter defects
What this means
Medline identified quality issues in certain lots of its Tonsil Pack Cath medical procedure kits. Problems include surface irregularities on the catheter, premature detachment of the catheter connector, and dimensional specifications not being met in some units.
- Check if you have Medline Tonsil Pack Cath (SKU DYNJ65199A) with lot numbers: 23HMI132, 23HMA956, 23GMA525, 23DMF610, 23AMH680, or 22CBF155.
- Do not use affected kits.
- Return them to your Medline supplier or contact Medline Industries for further instructions.
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-2494-2026More Medline recalls
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- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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