CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report

namic convenience kits labeled as: Pml,72,Adult,Fll-mll,-,Oem recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling namic convenience kits labeled as: Pml,72,Adult,Fll-mll,-,Oem, distributed nationwide in the US. The recall was initiated on 12 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 10193489067507 (each), 20193489067504 (case), Lot number 0000140528

Quantity recalled4400 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-1428-2025
FDA event ID: 96367
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 12 Feb 2025
FDA classified: 21 Mar 2025
Reported: 2 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Feb 2025	Recall initiated by company
21 Mar 2025	Classified by FDA	+37 days
2 Apr 2025	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

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

Product as listed by the FDA

namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit

Where it was distributed

Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia

Nationwide

Questions about this recall

Is namic convenience kits labeled as: Pml,72,Adult,Fll-mll,-,Oem recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled namic convenience kits labeled as: Pml,72,Adult,Fll-mll,-,Oem on 12 Feb 2025. The recall is Class II and its status is Ongoing. Recall number Z-1428-2025.

Why was it recalled?

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

Which lots are affected?

UDI/DI 10193489067507 (each), 20193489067504 (case), Lot number 0000140528

Where was it sold?

Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia

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.

More recalls from MEDLINE INDUSTRIES, LP - Northfield

All 792

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
3 Sep 2025Device	CLASS I	Medline ReNewal Reprocessed St. Jude Medical Response recalled	MEDLINE INDUSTRIES, LP - Northfield	Particulate Matter	Nationwide
3 Sep 2025Device	CLASS II	The Medline General Surgery Tray is customized to meet recalled	MEDLINE INDUSTRIES, LP - Northfield	Sterility	Nationwide
3 Sep 2025Device	CLASS II	Medline Kits containing BD SureStep Foley Tray Systems recalled	MEDLINE INDUSTRIES, LP - Northfield	Labeling Errors	FL, IL

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide