Medical device recalls Moderate risk

CENTURION Infusion Catheter recalled over labeling errors

Recall date
December 23, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
MEDLINE INDUSTRIES, LP - Northfield recalls CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
Recall number
Z-1048-2025
FDA classification
Class II
Brand / firm
MEDLINE INDUSTRIES, LP - Northfield
Sold / distributed
US: FL, KS, ND, PA, WA, WV, IL, WA

Why it was recalled

Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

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

What was recalled

CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.

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