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 1 Lot number: 38527131 (b) 2 Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133, (c) 3 Lot numbers: 38497294, 38564514, 40146320, 40990651 (d) 4 Lot 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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