Reported Dec 26, 2012 · Terminated

Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover;…

Medline 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: Medline Industries Inc · 1 Medline Pl · Mundelein, IL · 60060

Is this the product you have?

  • Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover
  • Product UsageThis Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure
Lot codes and dates
    • Reorder #CDS983828
    • lot numbers 12HD0901 and 12IB1848
    • expiration date 09/30/2013
Amount recalled
18 packs

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was 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.

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 Dec 17, 2012 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.