Medline Convenience Kits: 1) Drape Pack, Model Number: Dynj35363a; 2) Sick Kids-general Custom Split, Model Number: Sptpcd10005

Recall Summary Medline is recalling two types of convenience kits (Drape Pack Model DYNJ35363A and Sick Kids-General Custom Split Model SPTPCD10005) due to calibration problems with the sterilization and packaging equipment. The calibration issues may have affected whether the products were properly sterilized to the required standards. This recall affects all units of these two products that were processed through the affected equipment.

Product

Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SPLIT, Model Number: SPTPCD10005

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/fb29e213-88f1-4022-b868-419970557fcf