Recall Z-0532-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0532-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-15

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-10-15. FDA's recall record names no specific 510(k) clearance for this event. Product: (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.. Reason: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-10-15
Firm location: Northfield, IL, United States

Product description

(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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.