FDA-Device2024-12-04Class II
(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
Hazard
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Sold states
US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
Affected count
408 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
(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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0532-2025Don't want to check this manually?
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