FDAClass IIDecember 26, 2012

Medline Total Knee CDS recall: Sterility Concern

Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete…

Why was Medline Total Knee CDS recalled?

The Back Table Cover component in the custom pack was placed in the non-sterile portion of the pack when it should have been in the sterile portion.

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?

Reorder #CDS983828, lot numbers 12HD0901 and 12IB1848, expiration date 09/30/2013

Product
Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete…
Recalling firm
Medline Industries Inc
Quantity
18 packs
Distribution
US (nationwide) in the state of West Virginia
Recall date
December 26, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls