Medical device recalls Moderate risk

NS B LITE GLOVE 1000/CASE -Bulk recalled over sterility concerns

Recall date
April 16, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Covidien LLC recalls NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711
Recall number
Z-2117-2015
FDA classification
Class II
Brand / firm
Covidien LLC
Sold / distributed
Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingd…

Why it was recalled

Devon Light Gloves contain splits or holes compromising the sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711

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