Covidien LLC recalls Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fa

Recalled June 8, 2016 · FDA recall Z-1847-2016 · Covidien

Hazard

Compromised sterility due to breach of barrier · FDA Class II

Units

713600

Sold at

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

Description

Compromised sterility due to breach of barrier

Product

Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.

Manufacturer(s)

Covidien LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →