Reported Dec 14, 2016 · Terminated

Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with…

Halyard Health, 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: Halyard Health, Inc · 5405 Windward Pkwy · Alpharetta, GA · 30004-3894

Is this the product you have?

6 of 6 products

Products covered by this recall
Model / numberProduct as published
44965Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), NS
44966C-Section Drape with Clear Screen and Full Incise (Sterile), 00
44967C-Section Drape with Clear Screen (Non-Sterile), NS
44968C-Section Drape with Clear Screen (Sterile), 00
44977C-Section Drape with Pouch and Fenestration (Non-Sterile), NS
44978C-Section Drape with Pouch and Fenestration (Sterile), 00 Product Usage: A surgical drape is a device made of natural or synthetic materials intended to be use as a protective patient covering, such as to isolate a site or surgical incision from microbial and other contamination.
Amount recalled
132 cases

Where it was sold

Why it was recalled

Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access to the surgical site.

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 Feb 22, 2017 · Data as of Sep 19, 4:45 PM UTC

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