CLASS II ONGOING Device recall · Reported 5 Feb 2025 · FDA Enforcement Report

Centurion Infusion Catheter, 7F (DO) recalled by MEDLINE INDUSTRIES, LP

Medline Industries LP - Northfield is recalling Centurion Infusion Catheter, 7F (DO), distributed in 7 states. The recall was initiated on 23 Dec 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 10653160249979 (EA) 20653160249976 (CS), Lot Numbers: 2024103190, 2024050990, 2024021290, 2024012990, 2024111990
Quantity recalled1200 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1048-2025
FDA event ID
96066
Recalling firm
Medline Industries LP - Northfield, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
23 Dec 2024
FDA classified
29 Jan 2025
Reported
5 Feb 2025
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Labeling Errors

Timeline

23 Dec 2024Recall initiated by company
29 Jan 2025Classified by FDA+37 days
5 Feb 2025Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

US: FL, KS, ND, PA, WA, WV, IL, WA

FloridaIllinoisKansasNorth DakotaPennsylvaniaWashingtonWest Virginia

Questions about this recall

Why was it 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.

Which lots are affected?

UDI/DI 10653160249979 (EA) 20653160249976 (CS), Lot Numbers: 2024103190, 2024050990, 2024021290, 2024012990, 2024111990

Where was it sold?

US: FL, KS, ND, PA, WA, WV, IL, WA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 96066

This product is part of a recall event; the main page for the event is Medline Arterial Line Pack recalled by MEDLINE INDUSTRIES, LP.

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