Reported Jan 24, 2018 · Terminated

DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline…

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 Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads
  • labeled as follows(a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthro Pack 89-8687.02
  • Product Usagegeneral surgical
Lot codes and dates

4 of 4 products

Products covered by this recall
#Product as published
1Lot number: 38527131 (b)
2Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133, (c)
3Lot numbers: 38497294, 38564514, 40146320, 40990651 (d)
4Lot numbers: 41668816, 42839390, 44080575, 44871131, 45715430, 46232122
Amount recalled
226 kits

Where it was sold

Why it was recalled

DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.

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 Jun 21, 2018 · Data as of Sep 19, 6:06 PM UTC

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