FDA-Device2026-02-25Class IIPROCESSING DEFECT

Medline Convenience Kits DYNJ50806L recalled for sterilization equipment calibration issues

OTHERNationwide distribution

Stop using Medline Convenience Kits DYNJ50806L

Medline identified calibration problems with the equipment used to sterilize and package certain Convenience Kits (Model DYNJ50806L, Lot 23FBK937). While the products went through sterilization, the equipment calibration issues may have affected whether the devices are properly sterile. This could potentially compromise the safety of the medical devices.

  • Stop using the affected Medline Convenience Kits with Model Number DYNJ50806L and Lot Number 23FBK937
  • Contact your Medline representative or customer service for instructions on how to return or dispose of the product
  • If you have already used one of these kits, consult your healthcare provider if you have concerns
Hazard

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.

Sold states
Worldwide distribution - US Nationwide.
Affected count
32 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1403-2026

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