Medline Convenience Kits recalled due to sterilization equipment calibration issues
What this means
Medline identified calibration problems with equipment used to sterilize and package two models of convenience kits: the Drape Pack (Model DYNJ35363A) and Sick Kids-General Custom Split (Model SPTPCD10005). While the products went through sterilization cycles, the calibration issues may have affected whether the products remained properly sterile.
- Check if you have Lot Number 21BBP020 (Drape Pack) or Lot Number 24JBB041 (Sick Kids-General).
- Stop using affected kits and contact Medline Industries for instructions on return or replacement.
- If these kits were already used in medical procedures, consult with your healthcare provider.
The agency's original wording
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1409-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- 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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