FDA-Device2016-06-01Class II

Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

American Surgical Company
Hazard

Product packaging defective compromising sterility

Sold states
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.
Affected count
16 BOXES
Manufactured in
45 Congress St, N/A, Salem, MA, United States
Products
Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1811-2016

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