Covidien LLC recalls Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047
- Recall date
- March 3, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1849-2016
- FDA classification
- Class II
- Brand / firm
- Covidien LLC
- Sold / distributed
- 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.
Why it was recalled
Compromised sterility due to breach of barrier
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047
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