Z-1273-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- February 12, 2018
- Termination Date
- July 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,930 units
Product Description
ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
Reason for Recall
The concentration of bromocresol purple in the recalled lots does not conform to specification.
Distribution Pattern
United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan
Code Information
Lots: PS-673, PS-674, PS-675, PS-675