Medline Open Heart CDS recalled over sterility concerns
- Recall date
- October 15, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- MEDLINE INDUSTRIES, LP - Northfield recalls (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ90…
- Recall number
- Z-0532-2025
- FDA classification
- Class II
- Brand / firm
- MEDLINE INDUSTRIES, LP - Northfield
- Sold / distributed
- US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
Why it was recalled
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
(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.
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