CLASS II ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report

Centurion procedure kits labeled as: Cvc Insert Bundle, Pack Number recalled

Medline Industries LP - Northfield is recalling Centurion procedure kits labeled as: Cvc Insert Bundle, Pack Number. The recall was initiated on 8 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) ECVC3260, Lot Number 2021031650; 2) ECVC8105, Lot Number 2023012490

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-2516-2024
FDA event ID
94584
Recalling firm
Medline Industries LP - Northfield, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
8 Apr 2024
FDA classified
7 Aug 2024
Reported
14 Aug 2024
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Foreign Material

Timeline

8 Apr 2024Recall initiated by company
7 Aug 2024Classified by FDA+121 days
14 Aug 2024Published 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

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Which lots are affected?

1) ECVC3260, Lot Number 2021031650; 2) ECVC8105, Lot Number 2023012490

Where was it sold?

Worldwide distribution.

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 94584

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