Medline Convenience Kits: 1) Or Arteriogram, Model Number: Cds985094f; 2) Kit Surg Onc Lap Diag/cv Cath, Model Number: Dykmbndl153; 3) Kit Aces Insert Percutaneous T, Model Number: Dykmbndl4a;

Recall Summary Medline is recalling multiple surgical and catheterization convenience kits due to calibration problems with equipment used to sterilize and package these products. While the products went through sterilization cycles, the calibration issues may have affected whether the products are properly sterilized. These kits are used in hospitals and medical facilities for cardiac catheterization, angiography, and other surgical procedures.

Product

Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE KIT, Model Number: DYNDA2076C; 6) CARDIAC CATH PACK-LF, Model Number: DYNJ0150605AC; 7) CATH LAB PACK-LF, Model Number: DYNJ0648473Y; 8) NBMC CATH PACK-LF, Model Number: DYNJ0803367I; 9) ANGIO PACK-LF, Model Number: DYNJ0954970I; 10) CARDIAC CATH PACK, Model Number: DYNJ19946M; 11) CATH LAB PACK, Model Number: DYNJ30955I;...

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/6d214c79-a83a-41b1-9bf3-95e7b6e37f70