Class 2 Device Recall SporAmpule Biological Indicator

• Date Initiated by Firm: February 12, 2018
• Create Date: March 29, 2018
• Recall Status: Terminated on July 03, 2018
• Recall Number: Z-1274-2018
• Recall Event ID: 79374
• 510(K)Number: K971432
• Product Classification: Indicator, biological sterilization process - Product Code FRC
• 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
• Manufacturer Reason for Recall: The concentration of bromocresol purple in the recalled lots does not conform to specification.
• FDA Determined Cause: 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

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.

• 510(K) Database: 510(K)s with Product Code = FRC