FDAClass IIApril 1, 2020

Medline Winged Sponges Presaturated W/PVP recall: Sterility Concern

Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022.

Why was Medline Winged Sponges Presaturated W/PVP recalled?

Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

REF DYND70289 Expiration 06/30/2022

Product
Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022.
Recalling firm
Medline Industries Inc
Quantity
117,874 units
Distribution
US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI.
Recall date
April 1, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls