Medical device recalls Moderate risk

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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