FDAClass IIDecember 14, 2016

AMD-Ritmed Transparent Dressing - Window with label recall: Contamination

AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case…

Why was AMD-Ritmed Transparent Dressing - Window with label recalled?

The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.

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?

Lot 68408, expiration date 2018¿05

Product
AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case…
Recalling firm
Amd-Ritmed, Inc.
Quantity
US: 216 cases (200 dressings per case)
Distribution
NY, MA, VA, TN
Recall date
December 14, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls