Recall Z-1273-2018
Mesa Laboratories Bozeman Manufacturing Facility · initiated February 12, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
Codes / lots: Lots: PS-673, PS-674, PS-675, PS-675
Reason for recall
The concentration of bromocresol purple in the recalled lots does not conform to specification.
FDA-determined cause: Other
Action taken
Per the Recall Strategy, consignees have been requested to immediately discontinue use and discard according to site procedures.
Details
- Recall number
- Z-1273-2018
- Initiated
- February 12, 2018
- Terminated
- July 3, 2018
- Product code
- FRC – Indicator, Biological Sterilization Process
- Quantity
- 28,930 units
- Distribution
- United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan
- Recalling firm
- Mesa Laboratories Bozeman Manufacturing Facility, Boseman, MT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1274-2018 Class II | SporAmpule Biological Indicator Catalog Number SPS5-100The concentration of bromocresol purple in the recalled lots does not conform to specification. | 02/12/2018Terminated |