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Covidien LLC recalls Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in
Recalled April 12, 2017 · FDA recall Z-1743-2017 · Covidien
Hazard
Product sterility is compromised due to breach of sterile barrier · FDA Class II
Units
38794
Sold at
Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland, Israel, Italy, Kenya, Libya, Luxembourg, Mauritius, Namibia, Netherlands, Norway, Poland, Portugal, Russia, Russian Federation, Spain, Saudi Arabia, Seychelles, Slovakia, South Africa, Switzerland, UAE, and United Kingdom.
Description
Product sterility is compromised due to breach of sterile barrier
Product
Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
Manufacturer(s)
Covidien LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →