CLASS II ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report

Medline Convenience kits used for various procedures recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Convenience kits used for various procedures: Cstm Pacemaker Drape Pack, distributed nationwide in the US. The recall was initiated on 3 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) DYNJCD0339, UDI-DI: 10195327483753(each), 40195327483754(case), Lot Number: 24KBK055

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-1607-2025
FDA event ID: 96510
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 3 Mar 2025
FDA classified: 17 Apr 2025
Reported: 23 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Pacemakers & Defibrillators

Timeline

3 Mar 2025	Recall initiated by company
17 Apr 2025	Classified by FDA	+45 days
23 Apr 2025	Published in enforcement report	+6 days

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

Reason for recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

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

Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

Nationwide

Questions about this recall

Is Medline Convenience kits used for various procedures: Cstm Pacemaker Drape Pack recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Convenience kits used for various procedures: Cstm Pacemaker Drape Pack on 3 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1607-2025.

Why was it recalled?

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Which lots are affected?

1) DYNJCD0339, UDI-DI: 10195327483753(each), 40195327483754(case), Lot Number: 24KBK055

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

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

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1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
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