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Class 2 Device Recall SporAmpule Biological Indicator |
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| Date Initiated by Firm |
February 12, 2018 |
| Create Date |
March 29, 2018 |
| Recall Status1 |
Terminated 3 on July 03, 2018 |
| Recall Number |
Z-1274-2018 |
| Recall Event ID |
79374 |
| 510(K)Number |
K971432
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| Product Classification |
Indicator, biological sterilization process - Product Code FRC
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| Product |
SporAmpule Biological Indicator Catalog Number SPS5-100 |
| Code Information |
Lots: SPS-696, SPS-697, SPS-698 |
Recalling Firm/
Manufacturer |
Mesa Laboratories Bozeman Manufacturing Facility
625 Zoot Way
Boseman MT 59718
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Manufacturer Reason
for Recall |
The concentration of bromocresol purple in the recalled lots does not conform to specification.
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FDA Determined
Cause 2 |
Other |
| Action |
Per the Recall Strategy, consignees have been requested to immediately
discontinue use and discard according to site procedures. |
| Quantity in Commerce |
40,000 units |
| Distribution |
United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database |
510(K)s with Product Code = FRC and Original Applicant = RAVEN BIOLOGICAL LABORATORIES, INC.
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