Medical device recalls Moderate risk

American Surgical Company recalls American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Recall date
March 31, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1755-2016
FDA classification
Class II
Brand / firm
American Surgical Company
Sold / distributed
Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Canada, France, Germany, Greece, Hong Kong, Hong Kong, Israel, Italy, Italy, Japan, Netherlands, New Zealand, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

Why it was recalled

Product packaging defective compromising 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

American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges

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