Device product
Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Z-1811-2016
Product summary
- Event
- Event 73734
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 BOXES
- Official record key
device-enforcement:Z-1811-2016
Official wording
Reason: Product packaging defective compromising sterility
Code information: Lot numbers: Lot Number 2015/09 AI 2015/10 CR 2015/12 BV 2015/12 CV
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