FDAClass IIJanuary 24, 2018

DeRoyal Sterile Custom kits containing recall

DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads…

Why was DeRoyal Sterile Custom kits containing 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.

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?

(a) Lot number: 38527131 (b) Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133, (c) Lot numbers: 38497294, 38564514, 40146320, 40990651 (d) Lot numbers: 41668816, 42839390, 44080575, 44871131, 45715430, 46232122

Product
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads…
Recalling firm
DeRoyal Industries Inc
Quantity
226 kits
Distribution
Distributed to states of: CA and MO.
Recall date
January 24, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls