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U.S. Department of Health and Human Services

Class 2 Device Recall CROSSCHECKS P plasma sterilization indicator

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  Class 2 Device Recall CROSSCHECKS P plasma sterilization 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-1531-2010
Recall Event ID 52777
510(K)Number K083650  K024293  
Product Classification Plasma and steam sterilization indicators - Product Code JOJ
Product Violet Ink sterilization indicators Violet Ink (Class 6) and Violet Ink (Bowie Dick). Product numbers: CI 144, BD 115, PL 315, PL319, PL232, PL236, PL237, PL 238.
Code Information Lot numbers: 061001, 061101, 070201, 070401, 070601, 070701, 080101, 080801, 080901, 081001, 0900201, 090301, 090401, 090402
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 sterilization indicator products. There is insufficient data on file to support the shelf life dating on the product labeling.
FDA Determined
Cause 2		 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 2656 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, INC.
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