Reported Dec 4, 2024 · Ongoing

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

MEDLINE INDUSTRIES, LP - Northfield

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

    • (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
Lot codes and dates

3 of 3 products

Products covered by this recall
Model / numberBarcodesProduct as published
CDS840132O1019532724527640195327245277(1) - Lot number 24BBF701, exp. 10/31/2024, UDI-DI each 10195327245276, UDI-DI case 40195327245277
DYNJ903016G(2) - Lot numbers 24DBP801, exp. 8/31/2025
1019532765715440195327657155and 24CBJ749, exp. 11/30/2024, UDI-DI each - 10195327657154, UDI-DI case - 40195327657155.
Amount recalled
408 kits

This recall covers 12 products

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.