CLASS II Device recall · Reported 5 Feb 2020 · FDA Enforcement Report

Medline DYNDA1928 VP Tray With Pvp recalled by Medline Industries

Medline Industries is recalling Medline DYNDA1928 VP Tray With Pvp, distributed in Kentucky. The recall was initiated on 7 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCode DYNDA1928 Lot Number: 2019032190 Expiration Date 07/31/2020
Quantity recalled500

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-0865-2020
FDA event ID
84665
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Terminated
Recall initiated
7 Jan 2020
FDA classified
24 Jan 2020
Reported
5 Feb 2020
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

7 Jan 2020Recall initiated by company
24 Jan 2020Classified by FDA+17 days
5 Feb 2020Published 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

There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.

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 DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico

Where it was distributed

Kentucky. No governmental, Canadian, or Mexican consignees.

Kentucky

Questions about this recall

Why was it recalled?

There is potential for the sterile wrap to become loose while in transit and compromise the sterile barrier.

Which lots are affected?

Code DYNDA1928 Lot Number: 2019032190 Expiration Date 07/31/2020

Where was it sold?

Kentucky. No governmental, Canadian, or Mexican consignees.

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.

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