Device product
American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Z-1769-2016
Product summary
- Event
- Event 73734
- Status
- Terminated
- Classification
- Class II
- Quantity
- 449 boxes
- Official record key
device-enforcement:Z-1769-2016
Official wording
Reason: Product packaging defective compromising sterility
Code information: Lot numbers: 2015/09 AC 2015/09 BH 2015/10 AA 2015/10 BJ 2015/11 BC 2015/12 AU 2015/12 AK 2015/12 CK
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
Product packaging defective compromising sterility