Z-1274-2018 Class II Terminated
FDA device recall Z-1274-2018 was initiated by Mesa Laboratories Bozeman Manufacturing Facility on February 12, 2018 and is designated Class II. Reason for recall: The concentration of bromocresol purple in the recalled lots does not conform to specification. The recall status is terminated (terminated July 3, 2018). Affected quantity: 40,000 units.
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
- 40,000 units
Product Description
SporAmpule Biological Indicator Catalog Number SPS5-100
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: SPS-696, SPS-697, SPS-698