FDAClass IIOctober 26, 2016

CORE¿ Suction Irrigation Handpiece Y-Tubing set recall: Sterility Concern

CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE…

Why was CORE¿ Suction Irrigation Handpiece Y-Tubing set recalled?

The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

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?

Beginning Lot Code 110609X to Ending Lot Code 20160308X

Product
CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE…
Recalling firm
ConMed Corporation
Quantity
N/A
Distribution
Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
Recall date
October 26, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls