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Medline Industries recalls Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline…

Label example to identify the manufacturing date (red) and item number (blue) on the product label.
Label example to identify the manufacturing date (red) and item number (blue) on the product label. Image: FDA
Hudson RCI Neonatal/Infant Heated Wire Breathing Circuit Product photo
Hudson RCI Neonatal/Infant Heated Wire Breathing Circuit Product photo Image: FDA
Photo depicting defect showing signs of localized thermal damage
Photo depicting defect showing signs of localized thermal damage Image: FDA

What should I do?

Check whether you have this device (see the product and lot details below). If you do, stop using it and contact the company or your healthcare provider for next steps.

What's the hazard?

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

What's affected

Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS840171AG; 3) MHC AV FISTULA, Medline product number/SKU DYNJ903705K; 4) PERIPHERAL VASC MAJR-LF, Medline product number/SKU CDS840379O; 5) MINOR VASCULAR PACK-LF, Medline product number/SKU DYNJ0349727D; 6) SJHC VASCULAR PK-LF, Medline product number/SKU DYNJ19906L; 7) CABG PACK-LF, Medline product number/SKU DYNJ0824648K; 8) PERIPHERAL VASC MNR-LF, Medline product number/SKU DYNJ22721N; 9) HEART A PACK, Medline product number/SKU DYNJ0362405S; 10) OPEN HEART, Medline product number/SKU DYNJ907676I; 11) FEM POP MARYVIEW, Medline product number/SKU DYNJ911714; 12) CABG PACK, Medline product number/SKU DYNJ906346G; 13) DEBOER HEART MAIN, Medline product number/SKU DYNJ907914I; 14) OPEN HEART A & B PACK, Medline product number/SKU DYNJ9718008AU; 15) OPEN HEART, Medline product number/SKU DYNJ911483A; 16) CABG ACCESSORY PACK, Medline product number/SKU DYNJ59265; 17) HEART, Medline product number/SKU DYNJ908779B; 18) CARDIOVASCULAR PACK, Medline product number/SKU DYNJ69507F; 19) OFF PUMP CABG CDS, Medline product number/SKU CDS840087AN; 20) PACK CABG CHRG, Medline product number/SKU DYNJ905683D; 21) HEART CDS, Medline product number/SKU CDS840179N;

Read the official FDA recall announcement ↗

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