Reported Dec 13, 2017 · Terminated

DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads

DeRoyal Industries Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703

Is this the product you have?

DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads

7 of 7 products

Products covered by this recall
Model / numberProduct as published
47-763.04Incision and Drainage Tray
47-763.06Incision and Drainage Tray
47-763.07Incision and Drainage Tray
89-6752.01Cricothyreotomy Ambulance Kit
89-6818.02Incision and Drainage Tray
89-7212.04Plastic Pack
89-7212.05Plastic Pack, Product Usage: Custom surgical and procedural kits
Amount recalled
5946 units

Where it was sold

Why it was recalled

Custom surgical kits contain Aplicare Povidone Iodine Prep Pads which were subsequently recalled by Medline Industries for incorrect expiration date.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 21, 2020 · Data as of Sep 19, 4:44 PM UTC

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