FDAFDA · Food and drugs·Recall number Z-1800-2016
American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Published June 1, 2016 · Recall initiated: March 31, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product packaging defective compromising sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Surgical Company
- Distributor
- 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.
- Lot
- Lot numbers: 2015/12 AD
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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