CLASS II ONGOING Device recall · Reported 19 Jul 2023 · FDA Enforcement Report

Medline Non-sterile Pvp Solution recalled by MEDLINE INDUSTRIES, LP

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Non-sterile Pvp Solution, distributed nationwide in the US. The recall was initiated on 18 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) Model Number DYNJ64572A, UDI/DI (EA) 10195327112554, (CS) 40195327112555, Lot Numbers:23FBA458, 23DBC239 ; b) Model Number VAL050EEPKB, UDI/DI (EA) 10195327267149, (CS) 40195327267149, Lot Numbers: 23EBA381, 23CBI693, 23BBE528

Quantity recalled1500 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-2136-2023
FDA event ID: 92486
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 18 May 2023
FDA classified: 12 Jul 2023
Reported: 19 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

18 May 2023	Recall initiated by company
12 Jul 2023	Classified by FDA	+55 days
19 Jul 2023	Published 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

Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

Product as listed by the FDA

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB

Where it was distributed

Worldwide distribution - US Nationwide and the country of Panama.

Nationwide

Questions about this recall

Is Medline Non-sterile Pvp Solution recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Non-sterile Pvp Solution on 18 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2136-2023.

Why was it recalled?

Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

Which lots are affected?

a) Model Number DYNJ64572A, UDI/DI (EA) 10195327112554, (CS) 40195327112555, Lot Numbers:23FBA458, 23DBC239 ; b) Model Number VAL050EEPKB, UDI/DI (EA) 10195327267149, (CS) 40195327267149, Lot Numbers: 23EBA381, 23CBI693, 23BBE528

Where was it sold?

Worldwide distribution - US Nationwide and the country of Panama.

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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