Medline Convenience Kits: 1) Picc Line Tray, Model Number: 00-401993o; 2) Code Cart Adult 4 Central Line, Model Number: Acc010268b; 3) Code Cart Adult 4 Central Line, Model Number: Acc010268c;

Medline Convenience Kits Recall Summary Medline is recalling 24 models of medical convenience kits used for procedures involving central lines, PICC lines, and venous access across various patient populations. The kits were exposed to sterilization and packaging processes, but calibration problems with the sterilization equipment may have compromised the sterility of the products. This recall affects healthcare facilities that received these kits and the patients who may have been treated with them.

Product

Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY, Model Number: CVI3650; 6) LINE ATTIRE KIT, Model Number: DYKM2170; 7) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153C; 8) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43A; 9) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43C; 10) VEIN PROCEDURE KIT, Model Number: DYNDA2076B; 11) VEIN PROCEDURE...

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/4d4c893b-6de5-4f2f-a6cc-d54bc3517d18