CLASS II ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report

namic Convenience Kit, a) Carotid Manifold Kit recalled

Medline Industries LP - Northfield is recalling namic Convenience Kit, a) Carotid Manifold Kit, distributed nationwide in the US. The recall was initiated on 12 Mar 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) UDI/DI 10193489040456, Lot Numbers: 0000113192; b) UDI/DI 10193489044195, Lot Numbers: 0000113331; c) UDI/DI 10193489044386, Lot Numbers: 0000112999; d) UDI/DI 10193489044416, Lot Numbers: 0000113000; d) UDI/DI 10193489044935, Lot Numbers: 0000113187; e) UDI/DI f) UDI/DI g) UDI/DI h) UDI/DI i) UDI/DI j) UDI/DI k) UDI/DI l) UDI/DI m) UDI/DI n) UDI/DI o) UDI/DI p) UDI/DI q) UDI/DI

Quantity recalled570 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-1806-2024
FDA event ID: 94313
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 12 Mar 2024
FDA classified: 10 May 2024
Reported: 22 May 2024
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Other Medical Devices

Timeline

12 Mar 2024	Recall initiated by company
10 May 2024	Classified by FDA	+59 days
22 May 2024	Published in enforcement report	+12 days

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

Reason for recall

Products have a lack of sterility assurance.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION, REF 60140798; j) CONVENIENCE KIT, REF 60142592; k) LEFT HEART KIT, REF 60183972; l) FOUR VALVE MANIFOLD KIT, REF 60210209; m) RIGHT HEART KIT, REF 60210862; n) LEFT HEART KIT, REF 600705710; o) CONVENIENCE KIT, REF 600803410; p) TUBING KIT; REF 601322913; q) LEFT HEART KIT, REF 60032582A

Where it was distributed

US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.

Nationwide Alabama California Florida Georgia Kentucky Mississippi North Carolina Pennsylvania South Dakota Tennessee Texas Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

Products have a lack of sterility assurance.

Which lots are affected?

a) UDI/DI 10193489040456, Lot Numbers: 0000113192; b) UDI/DI 10193489044195, Lot Numbers: 0000113331; c) UDI/DI 10193489044386, Lot Numbers: 0000112999; d) UDI/DI 10193489044416, Lot Numbers: 0000113000; d) UDI/DI 10193489044935, Lot Numbers: 0000113187; e) UDI/DI f) UDI/DI g) UDI/DI h) UDI/DI i) UDI/DI j) UDI/DI k) UDI/DI l) UDI/DI m) UDI/DI n) UDI/DI o) UDI/DI p) UDI/DI q) UDI/DI

Where was it sold?

US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.

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 94313

This product is part of a recall event; the main page for the event is Namic Fluid Delivery Set recalled by MEDLINE INDUSTRIES, LP.

Reported	Class	Recall	Company	Reason	Where
22 May 2024	CLASS II	Namic Fluid Delivery Set recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Sterility	Nationwide

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