Medline Convenience Kits: 1) Kit Stc Tracheostomy, Model Number: Dykmbndl55; 2) Kit Stc Tracheostomy, Model Number: Dykmbndl55a; 3) Trach Tote, Model Number: Dynj85691
Recall Summary Medline is recalling three tracheostomy convenience kits (Models DYKMBNDL55, DYKMBNDL55A, and DYNJ85691) because calibration problems with sterilization equipment may have reduced their sterility assurance levels. While the products went through sterilization and packaging processes, the equipment issues could potentially compromise their sterile condition. This recall affects patients who use these tracheostomy kits.
- Product
- Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55A; 3) TRACH TOTE, Model Number: DYNJ85691
- Reason
- 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.
- Classification
- Class II
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-07
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/fa3c2b0c-b725-470f-b9f9-07496fb30c05