Hysto Pack recalled over sterility concerns

Recall date

April 16, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Covidien LLC recalls Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK

Recall number

Z-2119-2015

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

Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK