Device product
ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
Z-1273-2018
Product summary
- Event
- Event 79374
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28,930 units
- Official record key
device-enforcement:Z-1273-2018
Official wording
Reason: The concentration of bromocresol purple in the recalled lots does not conform to specification.
Code information: Lots: PS-673, PS-674, PS-675, PS-675
Distribution pattern: United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan
Derived failure modes
-
Unknown
The concentration of bromocresol purple in the recalled lots does not conform to specification.