Class II

Medical Device Recall: (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.

MEDLINE INDUSTRIES, LP - Northfield · October 15, 2024

Reason for Recall

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

Distribution

US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.

States Affected

NATIONWIDE

Quantity Affected

408 kits

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0532-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

MEDLINE INDUSTRIES, LP - Northfield Medical Device Recall: (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile. | SafeCheck