Medline Convenience Kits: 1) Open Heart Cds, Model Number: Cds840015aq; 2) Open Heart Cds, Model Number: Cds840023t; 3) Off Pump Cabg Cds, Model Number: Cds840087ai; 4) Off Pump Cabg Cds, Model

Recall Summary Medline is recalling multiple surgical convenience kits used in cardiac, vascular, and other surgical procedures because of calibration problems with the sterilization and packaging equipment. Although all products went through sterilization cycles, the calibration issues may have affected whether the products maintained proper sterility standards. These kits were distributed to hospitals and surgical facilities.

Product

Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OPEN HEART, Model Number: CDS840150S; 7) OPEN HEART, Model Number: CDS840150T; 8) OPEN HEART, Model Number: CDS840150U; 9) OPEN HEART, Model Number: CDS840150V; 10) OPEN HEART, Model Number: CDS840150W; 11) UNIVERSAL HEART CDS, Model Number: CDS840246O; 12) GENERAL AAA #11-RF, Model Number: CDS840261AB; 13) OPEN HEART ADULT,...

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/f1d23845-5e7b-47a3-bec4-3a064eb2c98b