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U.S. Department of Health and Human Services

Class 3 Device Recall STERITITE Containers

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  Class 3 Device Recall STERITITE Containers see related information
Date Initiated by Firm October 03, 2013
Date Posting Updated December 03, 2013
Recall Status1 Terminated 3 on January 13, 2014
Recall Number Z-0434-2014
Recall Event ID 66502
510(K)Number K030853  K023614  K080558  
Product Classification Wrap, sterilization - Product Code FRG
Product STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906.

The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.
Code Information 39

1085116, 1085638, 1085116, 1085116, 1085116, 1085116, 1085116

1084477, 1085638, 1084477

1084477, 1086154, 1084477, 1084477, 1086154, 1086154, 1086154, 1086154, 1086154, 1086154

1086154, 1087554, 1086154, 1087554, 1087554, 1087554, 1087554, 1087554, 1087554, 1086154, 1086154, 1086154, 1087554, 1087554, 1087554

1087554, 1087954, 1087954

1087554, 1087954, 1084038, 1084038, 1084038, 1084038, 1088118

1085116, 1088118, 1088118, 1088118, 1084038, 1085116, 1085116, 1085116, 1085116, 1085116, 1087673, 1085116, 1087673, 1087673, 1087673, 1087673, 1087673, 1087673, 1087673, 1085339

1085339, 1085638, 1085339, 1085638

1085638, 1086950, 1086950, 1086950, 1086422

1087554, 1087954, 1088118

1087954, 1088118

1086422, 1087954, 1087954, 1087954, 1087954, 1091472, 1089742

1089742, 1090276, 1090276, 1090276, 1090276, 1090276, 1090276, 1087673, 1087673, 1087673, 1087673

1087673, 1088647

1088647, 1089742, 1092105, 1090890, 1088647, 1086950

1087554, 1088118, 1089742, 1090276, 1091732, 1092105

1088118, 1088647, 1090890, 1087554, 1087554, 1088118, 1087554, 1087554, 1087554

1087554, 1087954, 1087954, 1088118, 1088118, 1088118, 1088118, 1088118, 1086154.
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact
949-453-6400
Manufacturer Reason
for Recall
Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed containers.
FDA Determined
Cause 2
Device Design
Action Advanced Sterilization Products (ASP) sent a Urgent Medical Device Field Safety Notification letter dated October 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers who received the SteriTite Containers. Customers were instructed to: Provide this notice to anyone in your facility that needs to be informed. Maintain a copy of this notice with the affected product. Maintain awareness of this notice. Customers are instructed to contact Stericycle at (888) 912-7092 for additional questions related to the recall letter. Customers are instructed to report any complaints or suspected problems related to the recall by contacting ASP at (888) STERRAD (888-783-7723).
Quantity in Commerce 267 units total (252 units in US)
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Vietnam, Thailand, Malaysia, China, Korea (South), Mexico, Spain, Singapore, Hong Kong and Portugal.
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 = FRG and Original Applicant = CASE MEDICAL, INC.
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