FDA-Device2016-06-01Class II

American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 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
4 boxes
Manufactured in
45 Congress St, N/A, Salem, MA, United States
Products
American Surgical Policot 1/2" x 1.5" Ref Number: 90-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1809-2016

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