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
| Model / number | Product as published |
|---|---|
44965 | Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), NS |
44966 | C-Section Drape with Clear Screen and Full Incise (Sterile), 00 |
44967 | C-Section Drape with Clear Screen (Non-Sterile), NS |
44968 | C-Section Drape with Clear Screen (Sterile), 00 |
44977 | C-Section Drape with Pouch and Fenestration (Non-Sterile), NS |
44978 | C-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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