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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 Posted December 03, 2013
Recall Status1 Terminated 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRG and Original Applicant = CASE MEDICAL, INC.
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