Medline Convenience Kits: 1) Kit Triple Lumen Insertion, Model Number: Dyndm1031a

Recall Summary Medline is recalling Triple Lumen Insertion Kits (Model DYNDM1031A) because equipment used to sterilize and package these kits had calibration problems that may have affected whether the products were properly sterilized. All affected kits went through sterilization processes, but the equipment issues mean their sterility cannot be guaranteed.

Product

Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A

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/9794a4ba-5c59-467c-86da-6f6370957b3f