FDA-Device2016-06-08Class II

Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047

Covidien LLC
Hazard

Compromised sterility due to breach of barrier

Sold states
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.
Affected count
2418560
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1849-2016

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