Class 2 Device Recall Plasma Chemical Indicator

• Date Initiated by Firm: July 15, 2009
• Date Posted: April 29, 2010
• Recall Status: Terminated on June 28, 2010
• Recall Number: Z-1532-2010
• Recall Event ID: 52777
• 510(K)Number: K972300
• Product Classification: Plasma Chemical Indicator - Product Code JOJ
• Product: Plasma Chemical Sterilization Indicator. Product Numbers Cl 115, PL 173, PL 205.
• Code Information: Lot Numbers: 070801, 080401, 080501, 080701, 081101.
• Recalling Firm/ Manufacturer: Steritec Products Mfc. Co., Inc.; 74 Inverness Dr E; Englewood CO 80112-5114
• For Additional Information Contact: 303-660-4201
• Manufacturer Reason for Recall: This action notifies affected SteriTec customers as well as private label distributors of the necessity to modify the shelf life of their products. There is insufficient data on file to support the shelf life dating on the product labeling.
• FDA Determined Cause: Other
• Action: Notify accounts by e-mail and letter, offering to exchange product for product with revised expiration date. Products exhausted by proper expiration date need not be returned or relabeled. Questions are directed to the firm at (303) 660-4201.
• Quantity in Commerce: 63 cases
• Distribution: Nationwide distribution: IL, MI, NY, OH, VA
• 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 = JOJ