CLASS II ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report

Sterile Pvp Solution recalled by MEDLINE INDUSTRIES, LP

MEDLINE INDUSTRIES, LP - Northfield is recalling Sterile Pvp Solution, distributed nationwide in the US. The recall was initiated on 3 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 40889942574491 (case), 10889942574490 (each), Lot numbers: 22LBL675, 22JBR599, 22IBS045, 22GBT655, 22DBN398, 22DBD250, 22DBA001, 21LBN032, 21JBA478, 21EBE405

Quantity recalled8250 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-0525-2024
FDA event ID: 93395
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 3 Nov 2023
FDA classified: 11 Dec 2023
Reported: 20 Dec 2023
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

3 Nov 2023	Recall initiated by company
11 Dec 2023	Classified by FDA	+38 days
20 Dec 2023	Published in enforcement report	+9 days

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

Reason for recall

The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

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

STERILE PVP SOLUTION, REF DYNDA1907

Where it was distributed

US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.

Nationwide California Connecticut Florida Iowa Louisiana Massachusetts New York Pennsylvania

Questions about this recall

Is Sterile Pvp Solution recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Sterile Pvp Solution on 3 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0525-2024.

Why was it recalled?

The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

Which lots are affected?

UDI/DI 40889942574491 (case), 10889942574490 (each), Lot numbers: 22LBL675, 22JBR599, 22IBS045, 22GBT655, 22DBN398, 22DBD250, 22DBA001, 21LBN032, 21JBA478, 21EBE405

Where was it sold?

US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.

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
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