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Recall Observatory FDA recall evidence

Device product

American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges

Z-1781-2016

March 31, 2016

Class II

Product summary

Firm
American Surgical Company
Event
Event 73734
Status
Terminated
Classification
Class II
Quantity
4 boxes
Official record key
device-enforcement:Z-1781-2016

Official wording

Reason: Product packaging defective compromising sterility

Code information: Lot numbers: 2015/10 CB

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product packaging defective compromising sterility