Medical device recalls Moderate risk

MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840

Recall date
August 28, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0124-2025
FDA classification
Class II
Brand / firm
MEDLINE INDUSTRIES, LP - Northfield
Sold / distributed
US Nationwide distribution.

Why it was recalled

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840

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