Medline Convenience Kits: 1) Ancillary Pack-lf, Model Number: Dynj0185290g; 2) Open Heart Anesthesia Icc-a, Model Number: Dynj905567a

Recall Summary Medline is recalling two convenience kits (Ancillary Pack-LF and Open Heart Anesthesia ICC-A) due to calibration problems with the sterilization and packaging equipment used to prepare them. While the products went through sterilization processes, the calibration issues could have affected whether the products were adequately sterilized. This recall affects all units of these two kits that were distributed.

Product

Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A

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 I

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/5a01a689-d518-4713-b777-609256c8c07d