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U.S. Department of Health and Human Services

Class 2 Device Recall Plasma Chemical Indicator

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  Class 2 Device Recall Plasma Chemical Indicator see related information
Date Initiated by Firm July 15, 2009
Date Posted April 29, 2010
Recall Status1 Terminated 3 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/
Steritec Products Mfc. Co., Inc.
74 Inverness Dr E
Englewood CO 80112-5114
For Additional Information Contact
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 2
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 and Original Applicant = STERITEC PRODUCTS MFG. CO., INC.